DiabetesPhase 3onset® 1NCT01831765

Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes

A Phase 3 study testing Faster-acting insulin aspart, insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 191 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp (faster-acting insulin aspart) compared to insulin aspart, both in combination with insulin detemir 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, insulin detemir and insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,290 participants
Where: 191 sitesin 9 countries
Study dates: 26 Aug 2013to 11 Jun 2015
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

Inclusion Criteria: - Type 1 diabetes (diagnosed clinically) for 12 months or longer at the time of screening (Visit 1) - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue (any regimen of insulin detemir or insulin glargine) for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index (BMI) below or equal to 35.0 kg/m^2 Exclusion Criteria: - Use of any anti-diabetic drug other than insulin within the last 3 months prior to screening (Visit 1) - Recurrent severe hypoglycaemia (more than one severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator, or hospitalisation for diabetic ketoacidosis during the previous 6 months prior to screening (Visit 1) - Cardiovascular disease, within the last 6 months prior to screening (Visit 1), defined as stroke, decompensated heart failure New York Heart Association (NYHA) class III or IV, myocardial infarction, unstable angina pectoris, coronary arterial bypass graft or angioplasty

Trial locations and contacts

191 sites in 9 countries.

Country

City, postcode or hospital

191 sites in 9 countries

United States116 sites

Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87106
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87109-2134
Novo Nordisk Investigational Site
Albuquerque, New Mexico, 87131
Novo Nordisk Investigational Site
Amarillo, Texas, 79106
Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Atlanta, Georgia, 30339
Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Baltimore, Maryland, 21204
Novo Nordisk Investigational Site
Baltimore, Maryland, 21287
Novo Nordisk Investigational Site
Beaumont, Texas, 77701
Novo Nordisk Investigational Site
Boca Raton, Florida, 33433
Novo Nordisk Investigational Site
Butte, Montana, 59701
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, 27517
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Chicago, Illinois, 60064
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Columbus, Ohio, 43201
Novo Nordisk Investigational Site
Concord, California, 94520
Novo Nordisk Investigational Site
Coral Gables, Florida, 33134
Novo Nordisk Investigational Site
Crystal Lake, Illinois, 60012
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75231
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dallas, Texas, 75390-9302
Novo Nordisk Investigational Site
Denver, Colorado, 80209
Novo Nordisk Investigational Site
Dunwoody, Georgia, 30338
Novo Nordisk Investigational Site
Eagan, Minnesota, 55123
Novo Nordisk Investigational Site
Escondido, California, 92025
Novo Nordisk Investigational Site
Fleming Island, Florida, 32203
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, 33308
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, 33312
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Fullerton, California, 92835
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834
Novo Nordisk Investigational Site
Greenville, South Carolina, 29605-4254
Novo Nordisk Investigational Site
Henderson, Nevada, 89052-2649
Novo Nordisk Investigational Site
Hoboken, New Jersey, 07030
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Houston, Texas, 77079
Novo Nordisk Investigational Site
Houston, Texas, 77099
Novo Nordisk Investigational Site
Hyattsville, Maryland, 20782
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Inglewood, California, 90301
Novo Nordisk Investigational Site
Jacksonville, Florida, 32204
Novo Nordisk Investigational Site
Jenkintown, Pennsylvania, 19046-3638
Novo Nordisk Investigational Site
Jersey City, New Jersey, 07306
Novo Nordisk Investigational Site
Kalamazoo, Michigan, 49048
Novo Nordisk Investigational Site
Kansas City, Missouri, 64106
Novo Nordisk Investigational Site
La Jolla, California, 92037
Novo Nordisk Investigational Site
La Mesa, California, 91942
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89128
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89148
Novo Nordisk Investigational Site
Lawrenceville, Georgia, 30046
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Lenexa, Kansas, 66219
Novo Nordisk Investigational Site
Lexington, Kentucky, 40502
Novo Nordisk Investigational Site
Lexington, Kentucky, 40503
Novo Nordisk Investigational Site
Long Beach, California, 90807
Novo Nordisk Investigational Site
Lubbock, Texas, 79423
Novo Nordisk Investigational Site
Magna, Utah, 84044
Novo Nordisk Investigational Site
Mentor, Ohio, 44060
Novo Nordisk Investigational Site
Miami, Florida, 33015
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Miami, Florida, 33156
Novo Nordisk Investigational Site
Miami, Florida, 33173
Novo Nordisk Investigational Site
Miami, Florida, 33174
Novo Nordisk Investigational Site
Minneapolis, Minnesota, 55416
Novo Nordisk Investigational Site
Mobile, Alabama, 36608
Novo Nordisk Investigational Site
Morehead City, North Carolina, 28557
Novo Nordisk Investigational Site
Muncie, Indiana, 47304
Novo Nordisk Investigational Site
Nampa, Idaho, 83686-6011
Novo Nordisk Investigational Site
Nashua, New Hampshire, 03063
Novo Nordisk Investigational Site
New York, New York, 10029
Novo Nordisk Investigational Site
Newark, Delaware, 19713
Novo Nordisk Investigational Site
North Hollywood, California, 91606
Novo Nordisk Investigational Site
Northridge, California, 91324
Novo Nordisk Investigational Site
Olympia, Washington, 98502
Novo Nordisk Investigational Site
Omaha, Nebraska, 68114
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19140-5103
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19140
Novo Nordisk Investigational Site
Plano, Texas, 75093
Novo Nordisk Investigational Site
Portland, Maine, 04101
Novo Nordisk Investigational Site
Portland, Oregon, 97210
Novo Nordisk Investigational Site
Portland, Oregon, 97239
Novo Nordisk Investigational Site
Poway, California, 92064
Novo Nordisk Investigational Site
Renton, Washington, 98057
Novo Nordisk Investigational Site
Rochester, New York, 14607
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Round Rock, Texas, 78681
Novo Nordisk Investigational Site
San Diego, California, 92037
Novo Nordisk Investigational Site
Sanford, Florida, 32771
Novo Nordisk Investigational Site
Santa Barbara, California, 93105-4321
Novo Nordisk Investigational Site
Santa Barbara, California, 93105
Novo Nordisk Investigational Site
Smithtown, New York, 11787
Novo Nordisk Investigational Site
Spokane, Washington, 99201
Novo Nordisk Investigational Site
Spokane, Washington, 99202-1334
Novo Nordisk Investigational Site
Spokane, Washington, 99202-3649
Novo Nordisk Investigational Site
Spokane, Washington, 99202
Novo Nordisk Investigational Site
Spokane, Washington, 99208
Novo Nordisk Investigational Site
Springfield, Illinois, 62711
Novo Nordisk Investigational Site
Springfield, Missouri, 65807
Novo Nordisk Investigational Site
Staten Island, New York, 10301-3901
Novo Nordisk Investigational Site
Staten Island, New York, 10301
Novo Nordisk Investigational Site
Sugar Land, Texas, 77479
Novo Nordisk Investigational Site
Tampa, Florida, 33614
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Tucson, Arizona, 85714
Novo Nordisk Investigational Site
Tucson, Arizona, 85724
Novo Nordisk Investigational Site
Ventura, California, 93003-2824
Novo Nordisk Investigational Site
Ventura, California, 93003
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Waltham, Massachusetts, 02453
Novo Nordisk Investigational Site
Worcester, Massachusetts, 01655

Other trials in United States

Germany25 sites

Novo Nordisk Investigational Site
Bad Mergentheim, 97980
Novo Nordisk Investigational Site
Berlin, 13597
Novo Nordisk Investigational Site
Damme, 49401
Novo Nordisk Investigational Site
Dresden, 01219
Novo Nordisk Investigational Site
Dresden, 01307
Novo Nordisk Investigational Site
Elsterwerda, 04910
Novo Nordisk Investigational Site
Falkensee, 14612
Novo Nordisk Investigational Site
Friedrichsthal, 66299
Novo Nordisk Investigational Site
Fulda, 36037
Novo Nordisk Investigational Site
Hamburg, 22607
Novo Nordisk Investigational Site
Hohenmölsen, 06679
Novo Nordisk Investigational Site
Lingen, 49808
Novo Nordisk Investigational Site
Ludwigshafen, 67059
Novo Nordisk Investigational Site
Münster, 48143
Novo Nordisk Investigational Site
Münster, 48145
Novo Nordisk Investigational Site
Neuwied, 56564
Novo Nordisk Investigational Site
Oldenburg, 23758
Novo Nordisk Investigational Site
Rehburg-Loccum, 31547
Novo Nordisk Investigational Site
Rehlingen-Siersburg, 66780
Novo Nordisk Investigational Site
Rostock, 18057
Novo Nordisk Investigational Site
Saint Ingbert-Oberwürzbach, 66386
Novo Nordisk Investigational Site
Schweinfurt, 97421
Novo Nordisk Investigational Site
Völklingen, 66333
Novo Nordisk Investigational Site
Wangen, 88239
Novo Nordisk Investigational Site
Zwenkau, 04442

Other trials in Germany

Canada12 sites

Novo Nordisk Investigational Site
Edmonton, Alberta, T5J 3N4
Novo Nordisk Investigational Site
Edmonton, Alberta, T6G 2E1
Novo Nordisk Investigational Site
Hamilton, Ontario, L8N 3Z5
Novo Nordisk Investigational Site
London, Ontario, N6A 4V2
Novo Nordisk Investigational Site
London, Ontario, N6G 2M1
Novo Nordisk Investigational Site
Mississauga, Ontario, L5M 2V8
Novo Nordisk Investigational Site
Montreal, Quebec, H2W 1R7
Novo Nordisk Investigational Site
Québec, G1V 4G2
Novo Nordisk Investigational Site
Sherbrooke, Quebec, J1G 5K2
Novo Nordisk Investigational Site
Toronto, Ontario, M5T 3L9
Novo Nordisk Investigational Site
Victoria, British Columbia, V8R 1J8
Novo Nordisk Investigational Site
Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

United Kingdom10 sites

Novo Nordisk Investigational Site
Bath, BA1 3NG
Novo Nordisk Investigational Site
Gillingham, ME7 5NY
Novo Nordisk Investigational Site
Glasgow, G21 3UW
Novo Nordisk Investigational Site
Guildford, GU2 7XX
Novo Nordisk Investigational Site
Inverness, IV2 3JH
Novo Nordisk Investigational Site
Inverness, IV2 3UJ
Novo Nordisk Investigational Site
Ipswich, IP4 5PD
Novo Nordisk Investigational Site
Nottingham, NG7 2UH
Novo Nordisk Investigational Site
Portsmouth, PO6 3LY
Novo Nordisk Investigational Site
Sheffield, S5 7AU

Other trials in United Kingdom

Finland6 sites

Novo Nordisk Investigational Site
Helsinki, 00260
Novo Nordisk Investigational Site
Kerava, FI-04200
Novo Nordisk Investigational Site
Lappeenranta, 53130
Novo Nordisk Investigational Site
Raisio, 21200
Novo Nordisk Investigational Site
Tampere, 33900
Novo Nordisk Investigational Site
Turku, FI-20100

Other trials in Finland

Hungary6 sites

Novo Nordisk Investigational Site
Budapest, 1076
Novo Nordisk Investigational Site
Budapest, 1089
Novo Nordisk Investigational Site
Debrecen, 4043
Novo Nordisk Investigational Site
Kaposvár, 7400
Novo Nordisk Investigational Site
Szeged, H-6720
Novo Nordisk Investigational Site
Szombathely, H-9700

Other trials in Hungary

Poland6 sites

Novo Nordisk Investigational Site
Bialystok, 15-435
Novo Nordisk Investigational Site
Gdansk, 80-858
Novo Nordisk Investigational Site
Krakow, 31-261
Novo Nordisk Investigational Site
Lublin, 20-538
Novo Nordisk Investigational Site
Szczecin, 70-376
Novo Nordisk Investigational Site
Warsaw, 02-507

Other trials in Poland

Belgium5 sites

Novo Nordisk Investigational Site
Bonheiden, 2820
Novo Nordisk Investigational Site
Brussels, 1070
Novo Nordisk Investigational Site
Edegem, 2650
Novo Nordisk Investigational Site
Ghent, 9000
Novo Nordisk Investigational Site
Leuven, 3000

Other trials in Belgium

Czechia5 sites

Novo Nordisk Investigational Site
Brno, 65691
Novo Nordisk Investigational Site
Hradec Králové, 50005
Novo Nordisk Investigational Site
Prague, 100 00
Novo Nordisk Investigational Site
Prague, 12808
Novo Nordisk Investigational Site
Prague, 140 21

Other trials in Czechia

About this study

Conditions: Diabetes, Diabetes Mellitus, Type 1
Being tested: Faster-acting insulin aspart, insulin detemir, 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 subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.
insulin detemirDrug
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
insulin aspartDrug
Injected subcutaneously (s.c., under the skin), dose individually adjusted.
Faster-acting insulin aspartDrug
Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.

Study groups in NCT01831765
Study group	Role	What they receive
Meal time FIAsp and insulin detemir	Experimental	Not described Receives: Drug: Faster-acting insulin aspart; Drug: insulin detemir
Meal time insulin aspart and insulin detemir	Active comparator	Not described Receives: Drug: insulin detemir; Drug: insulin aspart
Post meal FIAsp and insulin detemir	Experimental	Not described Receives: Drug: insulin detemir; Drug: Faster-acting insulin aspart

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Change from baseline in HbA1c after 26 weeks of randomised treatment.
Measured: Week 0, week 26

Secondary outcomes (7)

Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)
Change from baseline in 2-hour PPG increments after 26 weeks of randomised treatment (meal test).
Measured: Week 0, week 26
Change From Baseline in HbA1c (Post Meal Arm)
Change from baseline in HbA1c (post meal arm) after 26 weeks of randomised treatment.
Measured: Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Observed rate of treatment emergent severe or BG confirmed hypoglycaemic events per 100 patient years of exposure (PYE) from baseline until week 26. A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 1 day after the last day of randomised treatment. Severe or BG confirmed is an episode that is severe according to the American Diabetes Association (ADA) classification (an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a PG value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.
Measured: From baseline until week 26
Change From Baseline in Body Weight
Change from baseline in body weight after 26 weeks of randomised treatment.
Measured: Week 0, week 26
Frequency of Adverse Events
All treatment emergent adverse events (TEAEs) from baseline until 52 weeks of randomised treatment. A TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than 7 days after the last day of randomised treatment.
Measured: After 52 weeks of randomised treatment
Change in HbA1c
Change from baseline in HbA1c (%) after 52 weeks of randomised treatment.
Measured: Week 0, week 52
Change in PPG (Postprandial Glucose)
Change from baseline in PPG and PPG increment (meal test) after 52 weeks of randomised treatment.
Measured: Week 0, week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Aug 201311 Jun 2015

First posted15 Apr 2013 (estimated)
Study start26 Aug 2013
Primary completion12 May 2015
Study completion11 Jun 2015

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 (6)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: 1,290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01831765
Sponsor's protocol ID: NN1218-3852
Other IDs: 2010-024049-53, U1111-1118-2442
Acronym: onset® 1
Status last verified: May 2019
First submitted: 11 Apr 2013
Last updated: 12 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4.
PubMed 30949906
Russell-Jones D, Bode BW, De Block C, Franek E, Heller SR, Mathieu C, Philis-Tsimikas A, Rose L, Woo VC, Osterskov AB, Graungaard T, Bergenstal RM. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017 Jul;40(7):943-950. doi: 10.2337/dc16-1771. Epub 2017 Mar 29.
PubMed 28356319
Mathieu C, Bode BW, Franek E, Philis-Tsimikas A, Rose L, Graungaard T, Birk Osterskov A, Russell-Jones D. Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial. Diabetes Obes Metab. 2018 May;20(5):1148-1155. doi: 10.1111/dom.13205. Epub 2018 Feb 4.
PubMed 29316130
Bode BW, Bowering K, Russell-Jones D. Response to Comment on Russell-Jones et al. Diabetes Care 2017;40:943-950. Comment on Bowering et al. Diabetes Care 2017;40:951-957. Diabetes Care. 2018 Mar;41(3):e29-e30. doi: 10.2337/dci17-0051. No abstract available.
PubMed 29463670
Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
PubMed 30402720
Bowering K, Rodbard HW, Russell-Jones D, Bode B, Harris S, Piletic M, Heller S, Woo V, Babu V, Dethlefsen C, Mathieu C. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin Aspart in People with Diabetes: A Post Hoc Analysis. Diabetes Ther. 2019 Feb;10(1):177-188. doi: 10.1007/s13300-018-0553-7. Epub 2018 Dec 13.
PubMed 30547388

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 Diabetes
ClinicalTrials.gov ID: NCT01831765
Acronym / sponsor ID: onset® 1 / NN1218-3852
Conditions: Diabetes, Diabetes Mellitus, Type 1
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,290 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 26 Aug 2013 (actual)
Primary completion: 12 May 2015 (actual)
Study completion: 11 Jun 2015 (actual)
First posted: 15 Apr 2013 (estimated)
Results: Posted 23 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Meal time FIAsp and insulin detemir	Experimental	Drug: Faster-acting insulin aspart, Drug: insulin detemir
Meal time insulin aspart and insulin detemir	Active comparator	Drug: insulin detemir, Drug: insulin aspart
Post meal FIAsp and insulin detemir	Experimental	Drug: insulin detemir, Drug: Faster-acting insulin aspart

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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 subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.	Drug	Meal time FIAsp and insulin detemir
insulin detemirInjected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.	Drug	Meal time FIAsp and insulin detemir, Meal time insulin aspart and insulin detemir, Post meal FIAsp and insulin detemir
insulin aspartInjected subcutaneously (s.c., under the skin), dose individually adjusted.	Drug	Meal time insulin aspart and insulin detemir
Faster-acting insulin aspartInjected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.	Drug	Post meal FIAsp and insulin detemir

Primary outcome

Change From Baseline in HbA1c (Glycosylated Haemoglobin)
Time frame: Week 0, week 26
Change from baseline in HbA1c after 26 weeks of randomised treatment.

7 secondary outcomes

Change From Baseline in 2-hour PPG (Postprandial Glucose) Increment (Meal Test)
Time frame: Week 0, week 26
Change From Baseline in HbA1c (Post Meal Arm)
Time frame: Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Time frame: From baseline until week 26
Change From Baseline in Body Weight
Time frame: Week 0, week 26
Frequency of Adverse Events
Time frame: After 52 weeks of randomised treatment
Change in HbA1c
Time frame: Week 0, week 52
Change in PPG (Postprandial Glucose)
Time frame: Week 0, week 52

Results and safety

Results posted to the registry on 23 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Faster Aspart (Meal)	381	337
Faster Aspart (Post)	382	355
NovoRapid (Meal)	380	338

Primary outcome: Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Time frame: Week 0, week 26. Mean (Standard Deviation). Unit: Percentage of glycosylated haemoglobin

Measure	Faster Aspart (Meal) n = 381	Faster Aspart (Post) n = 382	NovoRapid (Meal) n = 380
Week 0 (Baseline)	7.62 (0.71)	7.63 (0.72)	7.58 (0.68)
Week 26	7.31 (0.77)	7.51 (0.77)	7.42 (0.78)

Faster Aspart (Meal) vs NovoRapid (Meal): Mean Difference (Net): -0.15 (95% CI -0.23 to -0.07)
Faster Aspart (Post) vs NovoRapid (Meal): Mean Difference (Net): 0.04 (95% CI -0.04 to 0.12)

Population analysed: The FAS included all randomised subjects. For this endpoint, baseline and week 26 have been presented, where week 26 data is end of trial containing last available measurement.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Until 52 weeks (26+26) weeks of treatment + 7 days followup for faster aspart (meal) and NovoRapid®(meal) or until 26 weeks of treatment + 7 days followup for faster aspart (post) + 30 day follow-up period for cardio-vascular related events.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Faster Aspart (Meal)	35 of 386 (9.1%)	252 of 386 (65.3%)	Not reported
Faster Aspart (Post)	28 of 377 (7.4%)	189 of 377 (50.1%)	Not reported
NovoRapid (Meal)	33 of 380 (8.7%)	236 of 380 (62.1%)	Not reported

Limitations and caveats (from the sponsor): Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30949906Rose L, Kadowaki T, Pieber TR, Buchholtz K, Ekelund M, Gorst-Rasmussen A, Philis-Tsimikas A. Efficacy and Safety of Fast-Acting Insulin Aspart in People with Type 1 Diabetes Using Carbohydrate Counting: A Post Hoc Analysis of Two Randomised Controlled Trials. Diabetes Ther. 2019 Jun;10(3):1029-1041. doi: 10.1007/s13300-019-0608-4. Epub 2019 Apr 4.
Results publication: PubMed 28356319Russell-Jones D, Bode BW, De Block C, Franek E, Heller SR, Mathieu C, Philis-Tsimikas A, Rose L, Woo VC, Osterskov AB, Graungaard T, Bergenstal RM. Fast-Acting Insulin Aspart Improves Glycemic Control in Basal-Bolus Treatment for Type 1 Diabetes: Results of a 26-Week Multicenter, Active-Controlled, Treat-to-Target, Randomized, Parallel-Group Trial (onset 1). Diabetes Care. 2017 Jul;40(7):943-950. doi: 10.2337/dc16-1771. Epub 2017 Mar 29.
Results publication: PubMed 29316130Mathieu C, Bode BW, Franek E, Philis-Tsimikas A, Rose L, Graungaard T, Birk Osterskov A, Russell-Jones D. Efficacy and safety of fast-acting insulin aspart in comparison with insulin aspart in type 1 diabetes (onset 1): A 52-week, randomized, treat-to-target, phase III trial. Diabetes Obes Metab. 2018 May;20(5):1148-1155. doi: 10.1111/dom.13205. Epub 2018 Feb 4.
Results publication: PubMed 29463670Bode BW, Bowering K, Russell-Jones D. Response to Comment on Russell-Jones et al. Diabetes Care 2017;40:943-950. Comment on Bowering et al. Diabetes Care 2017;40:951-957. Diabetes Care. 2018 Mar;41(3):e29-e30. doi: 10.2337/dci17-0051. No abstract available.
Results publication: PubMed 30402720Haahr H, Pieber TR, Mathieu C, Gondolf T, Shiramoto M, Erichsen L, Heise T. Clinical Pharmacology of Fast-Acting Insulin Aspart Versus Insulin Aspart Measured as Free or Total Insulin Aspart and the Relation to Anti-Insulin Aspart Antibody Levels in Subjects with Type 1 Diabetes Mellitus. Clin Pharmacokinet. 2019 May;58(5):639-649. doi: 10.1007/s40262-018-0718-6.
Results publication: PubMed 30547388Bowering K, Rodbard HW, Russell-Jones D, Bode B, Harris S, Piletic M, Heller S, Woo V, Babu V, Dethlefsen C, Mathieu C. Investigating the Association Between Baseline Characteristics (HbA1c and Body Mass Index) and Clinical Outcomes of Fast-Acting Insulin Aspart in People with Diabetes: A Post Hoc Analysis. Diabetes Ther. 2019 Feb;10(1):177-188. doi: 10.1007/s13300-018-0553-7. Epub 2018 Dec 13.
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

191 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, insulin detemir and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 1, run by Novo Nordisk A/S at 191 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?

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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, Germany, Canada, United Kingdom, Finland 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 23 Jan 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 From Baseline in HbA1c (Glycosylated Haemoglobin) (time frame: Week 0, week 26). 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 NCT01831765, which also lists 6 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 12 Jun 2019.