DiabetesPhase 3Onset® 5NCT02825251
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes
A Phase 3 study testing Faster-acting insulin aspart and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 92 sites in 9 countries.
Trial summary
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 1
- What is being tested?
- Faster-acting insulin aspart and insulin aspart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 472 participants
- Where
- 92 sitesin 9 countries
- Study dates
- 6 Jul 2016to 21 Jul 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age at least 18 years at the time of signing the informed consent
- Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
- Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
- HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
- Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening
- Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial
Who cannot join
- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
- Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol
Trial locations and contacts
92 sites in 9 countries.
92 sites in 9 countries
United States30 sites
Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Amarillo, Texas, 79106
Novo Nordisk Investigational Site
Arlington Heights, Illinois, 60005-4144
Novo Nordisk Investigational Site
Asheville, North Carolina, 28803
Novo Nordisk Investigational Site
Atlanta, Georgia, 30339
Novo Nordisk Investigational Site
Austin, Texas, 78749
Novo Nordisk Investigational Site
Boston, Massachusetts, 02215
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27517
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404-1192
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Encino, California, 91436
Novo Nordisk Investigational Site
Federal Way, Washington, 98003
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89148
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Mesquite, Texas, 75149
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
Nashua, New Hampshire, 03063
Novo Nordisk Investigational Site
Newark, Delaware, 19713
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15224-2215
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Roseville, California, 95661
Novo Nordisk Investigational Site
San Mateo, California, 94401
Novo Nordisk Investigational Site
San Ramon, California, 94583
Novo Nordisk Investigational Site
Santa Barbara, California, 93105
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
France10 sites
Novo Nordisk Investigational Site
Caen, 14033
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Montpellier, 34295
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Paris, 75010
Novo Nordisk Investigational Site
Saint-Herblain, 44800
Novo Nordisk Investigational Site
Strasbourg, 67098
Novo Nordisk Investigational Site
Toulouse, 31054
Novo Nordisk Investigational Site
Vénissieux, 69200
Netherlands10 sites
Novo Nordisk Investigational Site
Amsterdam, 1105 AZ
Novo Nordisk Investigational Site
Apeldoorn, 7334 DZ
Novo Nordisk Investigational Site
Eindhoven, 5631 BM
Novo Nordisk Investigational Site
Hoofddorp, 2134 TM
Novo Nordisk Investigational Site
Hoogeveen, 7909 AA
Novo Nordisk Investigational Site
Leiden, 2333 ZA
Novo Nordisk Investigational Site
Nijmegen, 6525 GA
Novo Nordisk Investigational Site
Rotterdam, 3011 TA
Novo Nordisk Investigational Site
Utrecht, 3584 CX
Novo Nordisk Investigational Site
Venlo, 5912 BL
Russia10 sites
Novo Nordisk Investigational Site
Cheboksary, 428009
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Novosibirsk, 630117
Novo Nordisk Investigational Site
Saint Petersburg, 190068
Novo Nordisk Investigational Site
Saint Petersburg, 194354
Novo Nordisk Investigational Site
Saint Petersburg, 195257
Novo Nordisk Investigational Site
Saint Petersburg, 199034
Novo Nordisk Investigational Site
Saint Petersburg, 199226
Novo Nordisk Investigational Site
Saratov, 410039
Novo Nordisk Investigational Site
Yoshkar-Ola, 424004
Germany9 sites
Novo Nordisk Investigational Site
Bad Mergentheim, 97980
Novo Nordisk Investigational Site
Essen, 45136
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Ludwigshafen, 67059
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Neuwied, 56564
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Rostock, 18057
Canada8 sites
Novo Nordisk Investigational Site
Barrie, Ontario, L4N 7L3
Novo Nordisk Investigational Site
Concord, Ontario, L4K 4M2
Novo Nordisk Investigational Site
Edmonton, Alberta, T6G 2E1
Novo Nordisk Investigational Site
London, Ontario, N6A 4V2
Novo Nordisk Investigational Site
Montreal, Quebec, H2X 0A9
Novo Nordisk Investigational Site
Oakville, Ontario, L6M 1M1
Novo Nordisk Investigational Site
Québec, G1V 4G2
Novo Nordisk Investigational Site
Toronto, Ontario, M4G 3E8
Belgium7 sites
Novo Nordisk Investigational Site
Arlon, 6700
Novo Nordisk Investigational Site
Bonheiden, 2820
Novo Nordisk Investigational Site
Brussels, 1090
Novo Nordisk Investigational Site
Edegem, 2650
Novo Nordisk Investigational Site
Leuven, 3000
Novo Nordisk Investigational Site
Sint-Niklaas, 9100
Novo Nordisk Investigational Site
Wilrijk, 2610
United Kingdom6 sites
Novo Nordisk Investigational Site
Cambridge, CB2 0QQ
Novo Nordisk Investigational Site
Guildford, GU2 7XX
Novo Nordisk Investigational Site
Harrogate, North Yorkshire, HG2 7SX
Novo Nordisk Investigational Site
London, SE1 9RT
Novo Nordisk Investigational Site
Manchester, M13 0JE
Novo Nordisk Investigational Site
St Helens, WA9 3DA
Slovenia2 sites
Novo Nordisk Investigational Site
Ljubljana, 1525
Novo Nordisk Investigational Site
Novo Mesto, 8000
About this study
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Being tested
- Faster-acting insulin aspart, insulin aspart
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faster-acting insulin aspartDrug
Injected s.c. /subcutaneously (under the skin)
insulin aspartDrug
Injected s.c. /subcutaneously (under the skin)
| Study group | Role | What they receive |
|---|---|---|
| Faster-acting insulin aspart CSII | Experimental | Not described Receives: Drug: Faster-acting insulin aspart |
| NovoRapid® CSII | Active comparator | Not described Receives: Drug: insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycosylated Haemoglobin (HbA1c)
Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.
Measured: Week 0, week 16
Secondary outcomes (90)
Change From Baseline in 1-hour PPG Increment
Change from baseline (week 0) in 1-hour postprandial glucose (PPG) increment was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, Week 16
Change From Baseline in 1,5-anhydroglucitol
Change from baseline (week 0) in 1,5-anhydroglucitol was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, Week 16
Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM
Change from baseline (week 0) in low interstitial glucose (IG) (≤3.9 mmol/L [70 mg/dL]) during continuous glucose monitoring (CGM) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)
Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.
Measured: Week 16
Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes
Percentage of subjects reaching HbA1c <7.0% (53 mmol/mol) without treatment emergent severe hypoglycaemic episodes was evaluated after 16 weeks of randomisation. Subjects without an HbA1c measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of IMP administration after randomisation (in week 0) and no later than one day after the last day on IMP (i.e., maximum week 16 + 1 day). The results are based on the in-trial period.
Measured: Week 16
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)
Change from baseline (week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour postprandial glucose (PPG [meal test]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
Measured: Week 0, week 16
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
Change from baseline (week 0) in 30-min, 2-hour, 3-hour and 4-hour PPG increment (meal test) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The subjects were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid®) infusion in the morning of the meal test. The subjects were to consume the meal as quickly as possible (within 12 minutes) and PPG was evaluated after 30 minutes, 1, 2, 3 and 4 hours from the start of the meal.
Measured: Week 0, week 16
Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile
Change from baseline (week 0) in mean of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. 7-7-9 point SMPG was measured at the following mentioned time points: 1) Before breakfast, 2) 60 mins after the start of Breakfast, 3) Before lunch, 4) 60 mins after the start of lunch, 5) Before main evening meal, 6) 60 mins after the start of main evening meal, 7) At bedtime, 8) At 4 AM, 9) Before breakfast.
Measured: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
Change from baseline (week 0) in PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
Change from baseline (week 0) in PPG increment (breakfast, lunch, main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)
Change from baseline (week 0) in pre-prandial PG (pre-breakfast, pre-lunch, pre-main evening meal and mean over all meals) of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile
Fluctuation in 7-point SMPG profile was the average absolute difference from the mean of the SMPG profile. Reported results are fluctuation in the 7-7-9 point SMPG profile at baseline (week 0) and after 16 weeks of randomisation (i.e., week 16). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements
Change from baseline (week 0) in nocturnal SMPG measurements was assessed by considering the differences between PG values available at bedtime, at 4 AM and the before breakfast value the following day: (4 AM PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 4 AM PG value). Change from baseline in nocturnal increments in SMPG measurements of the 7-7-9 point SMPG profile was evaluated after 16 weeks of randomisation and presented during three different time intervals as follows: 1) 04:00 to breakfast, 2) bedtime to 04:00, and 3) bedtime to breakfast. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]
Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. The results are based on the in-trial period.
Measured: Week 16
Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia
Percentage of subjects reaching overall PPG (1 hour) ≤7.8 mmol/L [140 mg/dL] without treatment emergent severe hypoglycaemia was evaluated after 16 weeks of randomisation. Subjects without a postprandial glucose measurement at week 16 were considered not to have achieved HbA1c target at week 16. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during an event, but neurological recovery following the return of PG to normal was considered sufficient evidence that the event was induced by a low PG concentration. The results are based on the in-trial period.
Measured: Week 16
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)
Reported results are lipids-lipoproteins (total cholesterol, high density lipoproteins, low density lipoproteins) values at baseline (week 0) and after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Insulin Dose in Units/Day: Total Basal
Total basal insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period. On-treatment period: the observation period from date of first dose of randomised trial products (faster aspart and NovoRapid®) to no later than 7 days after the day of last dose of randomised trial products.
Measured: Week 16
Insulin Dose in Units/Day: Total Bolus
Total bolus insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 16
Insulin Dose in Units/Day: Total Daily Insulin Dose
Total insulin dose (Units/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 16
Insulin Dose in Units/Day: Individual Meal Insulin Dose
No data was collected for individual meal insulin dose.
Measured: Week 16
Insulin Dose in Units/kg/Day: Total Basal
Total basal insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 16
Insulin Dose in Units/kg/Day: Total Bolus
Total bolus insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 16
Insulin Dose in Units/kg/Day: Total Daily Insulin Dose
Total insulin dose (Units/kg/day) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 16
Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose
No data was collected for individual meal insulin dose.
Measured: Week 16
Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio
Insulin carbohydrate ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 16
Insulin Delivery Pump Parameter: Glucose Sensitivity Factor
Glucose sensitivity factor was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 16
Insulin Delivery Pump Parameter: Active Insulin Time
Active insulin time was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 16
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)
Change from baseline (week 0) in mean interstitial glucose (IG) increment (0-30 minutes (min), 0-1 hour (h) and 0-2 h after start of meal) (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
Change from baseline (week 0) in mean time to the IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
Change from baseline (week 0) in mean IG peak after start of meal (breakfast, lunch, main evening meal and mean across all meals) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
Percentage of time spent with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 16
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
Incidence of episodes with IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL]) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 16
Change From Baseline in Mean of the IG Profile
Change from baseline (week 0) in mean of the IG profile was evaluated after 16 weeks of randomisation. The mean of an IG profile is defined as the time integral of the profile over the profile's length, divided by the profile's length. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)
Percentage of time spent within IG target range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 16
Variation in the IG Profile
Variation in IG profile was the average absolute difference from the mean of the IG profile. Variation in the IG profile was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 16
Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]
Area under the curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL] was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 16
Change From Baseline in AUCIG,0-15min
Change from baseline (week 0) in area under the curve for interstitial glucose (AUCIG),0-15 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline in AUCIG,0-30min
Change from baseline (week 0) in AUCIG,0-30 minutes during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline in AUCIG,0-1h
Change from baseline (week 0) in AUCIG,0-1 hour during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline in AUCIG,0-2h
Change from baseline (week 0) in AUCIG,0-2 hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline in AUCIG,0-4h
Change from baseline (week 0) in AUCIG,0-24hours during meal test was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline in Time to the IG Peak After Start of Meal
Change from baseline (week 0) in time to the IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Change From Baseline in IG Peak After Start of Meal
Change from baseline (week 0) in IG peak after start of meal-test meal was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Measured: Week 0, week 16
Number of Treatment Emergent Adverse Events (AEs)
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 16. A TEAE was defined as an event that has an onset date on or after the first day of exposure to randomised treatment (in week 0), and no later than seven days after the last day of randomised treatment (i.e., maximum week 16 + 7 days). The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Infusion Site Reactions
Number of treatment emergent infusion site reactions were recorded from week 0 to week 16. The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall
ADA classification of hypo:
- Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level.
- Documented symptomatic: PG ≤3.9 mmol/L with symptoms.
- Asymptomatic: PG ≤3.9 mmol/L without symptoms.
- Probable symptomatic: No measurement with symptoms.
- Pseudo: PG >3.9 mmol/L with symptoms.
- Unclassifiable.
NN classification of hypo:
- BG confirmed: PG <3.1 mmol/L with/without symptoms.
- Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms.
- Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms.
- Unclassifiable.
Not able to self treat-unclassifiable: Not able to self treat but not classifiable as severe hypo.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)
Number of treatment emergent day time hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 06:00 and 00:00 (both included). The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
Number of treatment emergent nocturnal hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 00:01 and 05:59 (both included). The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 1 hour after start of the meal. The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 2 hours after start of the meal. The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated during the first 4 hours after start of the meal. The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 4 hours after start of the meal. The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 1 Hour to 2 Hours After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 1 hour to 2 hours after start of the meal. The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 2 to 3 Hours After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 2 to 3 hours after start of the meal. The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes Occurring Between 3 to 4 Hours After Start of the Meal
Number of treatment emergent hypoglycaemic episodes according to the ADA and NN definitions were evaluated between 3 to 4 hours after start of the meal. The results are based on the on-treatment period.
Measured: Weeks 0-16
Number of Unexplained Episodes of Hyperglycaemia (Confirmed by SMPG)
Unexplained hyperglycaemia was defined as a confirmed PG value ≥16.7 mmol/L (300 mg/dL) and was unexplained (i.e. no apparent medical, dietary, insulin dosage or pump failure reason). The results are based on the on-treatment period.
Measured: Weeks 0-16
Change From Baseline in Physical Examination: Respiratory System
Reported results are respiratory system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Physical Examination: Cardiovascular System
Reported results are cardiovascular system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Physical Examination: Central and Peripheral Nervous System
Reported results are central and peripheral nervous system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Physical Examination: Gastrointestinal System, Including the Mouth
Reported results are gastrointestinal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Physical Examination: Musculoskeletal System
Reported results are musculoskeletal system-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Physical Examination: Skin
Reported results are skin-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Physical Examination: Head, Ears, Eyes, Nose, Throat and Neck
Reported results are head, ears, eyes, nose, throat and neck-examination findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Vital Sign: Blood Pressure
Change from baseline (week 0) in blood pressure (both systolic and diastolic) was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Vital Sign: Pulse
Change from baseline (week 0) in pulse was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Screening in Electrocardiogram (ECG)
Reported results are ECG findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) Abnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Screening in Fundus Photography/Fundoscopy
Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening (week -6) and after 16 weeks of randomisation. The findings are presented as: 1) Normal. 2) AAbnormal (not clinically significant [NCS]). 3) Abnormal (clinically significant [CS]). The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Haematology: Haemoglobin
Change from baseline (week 0) in haemoglobin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Haematology: Haematocrit
Change from baseline (week 0) in haematocrit was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Haematology: Erythrocytes
Change from baseline (week 0) in erythrocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Haematology: Thrombocytes
Change from baseline (week 0) in thrombocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Haematology: Leucocytes
Change from baseline (week 0) in leucocytes was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Biochemistry: Total Protein
Change from baseline (week 0) in total protein was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Biochemistry: Creatinine
Change from baseline (week 0) in creatinine was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Biochemistry: Alanine Aminotransferase (ALT)
Change from baseline (week 0) in ALT was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Biochemistry: Aspartate Aminotransferase (AST)
Change from baseline (week 0) in AST was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Biochemistry: Alkaline Phosphatase (ALP)
Change from baseline (week 0) in ALP was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Biochemistry: Sodium
Change from baseline (week 0) in sodium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Biochemistry: Potassium
Change from baseline (week 0) in potassium was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Biochemistry: Albumin
Change from baseline (week 0) in albumin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Biochemistry: Total Bilirubin
Change from baseline (week 0) in bilirubin was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Urinalysis: Albumin/Creatine Ratio
Change from baseline (week 0) in albumin/creatine ratio was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Urinalysis: Erythrocytes
Reported results are urine erythrocytes-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ and e) 3+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Urinalysis: Protein
Reported results are urine protein-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Urinalysis: Ketones
Reported results are urine ketone-test findings at baseline (week 0) and after 16 weeks of randomisation. The findings are presented as: a) Negative, b) Trace, c) 1+, d) 2+ e) 3+ and f) 4+. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Body Weight
Change from baseline (week 0) in body weight was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Change From Baseline in Body Mass Index (BMI)
Change from baseline (week 0) in BMI was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0, week 16
Number of Change-of-infusion-sets Per Week
Number of change-of-infusion-sets per week was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Measured: Week 0-16
Number of Subjects With at Least One Non-routine Change-of-infusion-sets Categorised by Reasons for Change-of-infusion-sets
Number of subjects with at least one non-routine change-of-infusion-sets categorised by reasons for change-of-infusion-sets was evaluated from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Reasons for change-of-infusion-sets are categorised as follows:
Category-1: A perceived occlusion by the subject Category-2: Any problems related to the infusion set Category-3: Any technical issues with the pump Category-4: Changes in the insulin solution in the infusion set or reservoir Category-5: High BG with no other explanation which made the subject change the infusion set Category-6: Infusion site reaction Category-7: Missing
Measured: Week 0-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start6 Jul 2016
- Primary completion20 Jun 2017
- Study completion21 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 472 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825251
- Sponsor's protocol ID
- NN1218-3854
- Other IDs
- 2010-024054-11, U1111-1118-2480, NL54555.018.16
- Acronym
- Onset® 5
- Status last verified
- Nov 2019
- First submitted
- 4 Jul 2016
- Last updated
- 21 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.
PubMed 28918652Klonoff DC, Evans ML, Lane W, Kempe HP, Renard E, DeVries JH, Graungaard T, Hyseni A, Gondolf T, Battelino T. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019 Apr;21(4):961-967. doi: 10.1111/dom.13610. Epub 2019 Jan 13.
PubMed 30537180Gorst-Rasmussen A, Sturis J, Ekelund M. Continuous Glucose Monitoring Sensor Glucose Levels and Insulin Pump Infusion Set Wear-Time During Treatment with Fast-Acting Insulin Aspart: A Post Hoc Analysis of Onset 5. Diabetes Technol Ther. 2022 Jan;24(1):10-17. doi: 10.1089/dia.2021.0199. Epub 2021 Dec 14.
PubMed 34524005
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart Compared to NovoRapid® in Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02825251
- Acronym / sponsor ID
- Onset® 5 / NN1218-3854
- Conditions
- Diabetes, Diabetes Mellitus, Type 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2016 (actual)
- Primary completion
- 20 Jun 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Posted 24 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate efficacy and safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faster-acting insulin aspart CSII | Experimental | Drug: Faster-acting insulin aspart |
| NovoRapid® CSII | Active comparator | Drug: insulin aspart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, age at least 18 years at the time of signing the informed consent
- Diagnosed with T1DM (Type 1 Diabetes Mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening
- Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
- HbA1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
- Body mass index (BMI) below or equal to 35.0 kg/m^2 at screening
Key exclusion criteria (5 listed)
- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- History of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
- Any condition which, in the opinion of the Investigator, might jeopardise a Subject's safety or compliance with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faster-acting insulin aspartInjected s.c. /subcutaneously (under the skin) | Drug | Faster-acting insulin aspart CSII |
| insulin aspartInjected s.c. /subcutaneously (under the skin) | Drug | NovoRapid® CSII |
Primary outcome
Change in Glycosylated Haemoglobin (HbA1c)
Time frame: Week 0, week 16
Change from baseline (week 0) in HbA1c was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.
90 secondary outcomes
Change From Baseline in 1-hour PPG Increment
Time frame: Week 0, Week 16
Change From Baseline in 1,5-anhydroglucitol
Time frame: Week 0, Week 16
Change From Baseline in Time Spent in Low IG (≤3.9 mmol/L [70 mg/dL]) During CGM
Time frame: Week 0, week 16
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 16
Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol)
Time frame: Week 16
Percentage of Subjects Reaching HbA1c <7.0% (53 mmol/Mol) Without Severe Hypoglycaemic Episodes
Time frame: Week 16
Change From Baseline in 30-min, 1-hour, 2-hour, 3-hour and 4-hour PPG (Meal Test)
Time frame: Week 0, week 16
Change From Baseline in 30-min, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)
Time frame: Week 0, week 16
Change From Baseline in Mean of the 7-7-9 Point Self-measured Plasma Glucose (SMPG) Profile
Time frame: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)
Time frame: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)
Time frame: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: Pre-prandial Plasma Glucose (PG) (Mean, Pre-breakfast, Pre-lunch, Pre-main Evening Meal)
Time frame: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: Fluctuation in 7-7-9 Point Profile
Time frame: Week 0, week 16
Change From Baseline of the 7-7-9 Point SMPG Profile: in Nocturnal SMPG Measurements
Time frame: Week 0, week 16
Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL]
Time frame: Week 16
Percentage of Subjects Reaching Overall PPG (1 Hour) ≤7.8 mmol/L [140 mg/dL] Without Severe Hypoglycaemia
Time frame: Week 16
Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins)
Time frame: Week 0, week 16
Insulin Dose in Units/Day: Total Basal
Time frame: Week 16
Insulin Dose in Units/Day: Total Bolus
Time frame: Week 16
Insulin Dose in Units/Day: Total Daily Insulin Dose
Time frame: Week 16
Insulin Dose in Units/Day: Individual Meal Insulin Dose
Time frame: Week 16
Insulin Dose in Units/kg/Day: Total Basal
Time frame: Week 16
Insulin Dose in Units/kg/Day: Total Bolus
Time frame: Week 16
Insulin Dose in Units/kg/Day: Total Daily Insulin Dose
Time frame: Week 16
Insulin Dose in Units/kg/Day: Individual Meal Insulin Dose
Time frame: Week 16
Insulin Delivery Pump Parameter: Insulin Carbohydrate Ratio
Time frame: Week 16
Insulin Delivery Pump Parameter: Glucose Sensitivity Factor
Time frame: Week 16
Insulin Delivery Pump Parameter: Active Insulin Time
Time frame: Week 16
Change From Baseline in Mean IG Increment (0-30 Min, 0-1 Hour and 0-2 Hours After Start of Meal) (Mean, Breakfast, Lunch and Main Evening Meal)
Time frame: Week 0, week 16
Change From Baseline in Mean Time to the IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
Time frame: Week 0, week 16
Change From Baseline in Mean IG Peak After Start of Meal (Mean, Breakfast, Lunch and Main Evening Meal)
Time frame: Week 0, week 16
Percentage of Time Spent With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
Time frame: Week 16
Incidence of Episodes With IG ≤2.5, 3.0, 3.5, 3.9 mmol/L [45, 54, 63, 70 mg/dL]) and IG >10.0, 12.0, 13.9 mmol/L [180, 216, 250 mg/dL])
Time frame: Week 16
Change From Baseline in Mean of the IG Profile
Time frame: Week 0, week 16
Percentage of Time Spent Within IG Target Range 4.0-7.8 mmol/L (71-140 mg/dL) and 4.0-10 mmol/L (71-180 mg/dL)
Time frame: Week 16
Variation in the IG Profile
Time frame: Week 16
Area Under the Curve (AUC3.9-IG) for IG ≤3.9 mmol/L [70 mg/dL]
Time frame: Week 16
Change From Baseline in AUCIG,0-15min
Time frame: Week 0, week 16
Change From Baseline in AUCIG,0-30min
Time frame: Week 0, week 16
Change From Baseline in AUCIG,0-1h
Time frame: Week 0, week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28918652Zijlstra E, Demissie M, Graungaard T, Heise T, Nosek L, Bode B. Investigation of Pump Compatibility of Fast-Acting Insulin Aspart in Subjects With Type 1 Diabetes. J Diabetes Sci Technol. 2018 Jan;12(1):145-151. doi: 10.1177/1932296817730375. Epub 2017 Sep 18.
- Results publication: PubMed 30537180Klonoff DC, Evans ML, Lane W, Kempe HP, Renard E, DeVries JH, Graungaard T, Hyseni A, Gondolf T, Battelino T. A randomized, multicentre trial evaluating the efficacy and safety of fast-acting insulin aspart in continuous subcutaneous insulin infusion in adults with type 1 diabetes (onset 5). Diabetes Obes Metab. 2019 Apr;21(4):961-967. doi: 10.1111/dom.13610. Epub 2019 Jan 13.
- Derived from this study: PubMed 34524005Gorst-Rasmussen A, Sturis J, Ekelund M. Continuous Glucose Monitoring Sensor Glucose Levels and Insulin Pump Infusion Set Wear-Time During Treatment with Fast-Acting Insulin Aspart: A Post Hoc Analysis of Onset 5. Diabetes Technol Ther. 2022 Jan;24(1):10-17. doi: 10.1089/dia.2021.0199. Epub 2021 Dec 14.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
92 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Faster-acting insulin aspart and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 92 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 92 sites in United States, France, Netherlands, Russia, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycosylated Haemoglobin (HbA1c) (time frame: Week 0, week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02825251, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.