DiabetesPhase 3onset® 2NCT01819129

Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes

A Phase 3 study testing Faster-acting insulin aspart, Insulin aspart and Insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 144 sites in 10 countries.

Completed

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

Official record

Search all trials

Trial summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare FIAsp (faster-acting insulin aspart) to insulin aspart, both in combination with insulin glargine and metformin in adults with type 2 diabetes. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: Faster-acting insulin aspart, Insulin aspart and Insulin glargine
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 881 participants
Where: 144 sitesin 10 countries
Study dates: 9 Sep 2013to 22 Jan 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 2 diabetes (diagnosed clinically) for 6 months or longer at time of screening (visit 1) - Treated with basal insulin for at least 6 months prior to screening (visit 1) - Current once daily treatment with insulin NPH (Neutral Protamine Hagedorn), insulin detemir or glargine for at least 3 months prior to the screening visit (visit 1) - Current treatment with: a. metformin with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg or b. metformin in combination with sulfonylurea (SU) or glinide or DPP-IV (dipeptidyl peptidase-4) inhibitors and/or alpha-glucosidase inhibitors (AGI) with unchanged dosing for at least 3 months prior to screening (visit 1). The metformin dose must be at least 1000 mg - HbA1c by central laboratory: a. 7.0 - 9.5% (53 - 80 mmol/mol) (both inclusive) in the metformin group at the screening visit (visit 1) or b. 7.0 - 9.0% (53 - 75 mmol/mol) (both inclusive) in the metformin + other OAD (oral antidiabetic drug) (SU, glinide, DDP-IV inhibitors, AGI) combination group at the screening visit (visit 1) - Body mass index (BMI) equal to or below 40.0 kg/m^2 Exclusion Criteria: - Any use of bolus insulin, except short-term use due to intermittent illness (no longer than 14 days consecutive treatment) and not 3 months prior to the screening visit (visit 1) - Use of GLP-1 (glucagon-like peptide-1) agonists and/or TZDs within the last 3 months prior to screening (visit 1) - Recurrent severe hypoglycaemia (more than 1 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 or coronary arterial bypass graft or angioplasty

Trial locations and contacts

144 sites in 10 countries.

Country

City, postcode or hospital

144 sites in 10 countries

United States77 sites

Novo Nordisk Investigational Site
Anaheim, California, 92801
Novo Nordisk Investigational Site
Atlanta, Georgia, 30308-2253
Novo Nordisk Investigational Site
Atlanta, Georgia, 30328
Novo Nordisk Investigational Site
Aurora, Colorado, 80045
Novo Nordisk Investigational Site
Avon, Illinois, 46123
Novo Nordisk Investigational Site
Boynton Beach, Florida, 33472
Novo Nordisk Investigational Site
Bradenton, Florida, 34201
Novo Nordisk Investigational Site
Buckley, Michigan, 49620
Novo Nordisk Investigational Site
Butte, Montana, 59701
Novo Nordisk Investigational Site
Carlisle, Ohio, 45005
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404-1192
Novo Nordisk Investigational Site
Chesterfield, Missouri, 63017
Novo Nordisk Investigational Site
Cleveland, Ohio, 44122
Novo Nordisk Investigational Site
Colorado Springs, Colorado, 80910
Novo Nordisk Investigational Site
Cooper City, Florida, 33024
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75251
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Decatur, Georgia, 30033
Novo Nordisk Investigational Site
Detroit, Michigan, 48201
Novo Nordisk Investigational Site
East Providence, Rhode Island, 02914
Novo Nordisk Investigational Site
Elkhorn, Nebraska, 68022
Novo Nordisk Investigational Site
Fort Lauderdale, Florida, 33316
Novo Nordisk Investigational Site
Franklin, Ohio, 45005
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Gaffney, South Carolina, 29341
Novo Nordisk Investigational Site
Glendale, Arizona, 85306-4652
Novo Nordisk Investigational Site
Glendale, Arizona, 85308
Novo Nordisk Investigational Site
Greenbrae, California, 94904
Novo Nordisk Investigational Site
Hickory, North Carolina, 28601
Novo Nordisk Investigational Site
Hurst, Texas, 76054
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46254
Novo Nordisk Investigational Site
Jacksonville, Florida, 32205
Novo Nordisk Investigational Site
Jacksonville, Florida, 32216
Novo Nordisk Investigational Site
Jefferson City, Missouri, 65109
Novo Nordisk Investigational Site
Kenosha, Wisconsin, 53144
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Lomita, California, 90717
Novo Nordisk Investigational Site
Louisville, Kentucky, 40206
Novo Nordisk Investigational Site
Madisonville, Kentucky, 42431-1661
Novo Nordisk Investigational Site
Mason, Ohio, 45040-6815
Novo Nordisk Investigational Site
Mesa, Arizona, 85213
Novo Nordisk Investigational Site
Miami, Florida, 33144
Novo Nordisk Investigational Site
Miami, Florida, 33173
Novo Nordisk Investigational Site
Midlothian, Virginia, 23114
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, 53209
Novo Nordisk Investigational Site
Mineola, New York, 11501
Novo Nordisk Investigational Site
Monroe, Louisiana, 71203
Novo Nordisk Investigational Site
Muncie, Indiana, 47304
Novo Nordisk Investigational Site
Murray, Utah, 84123
Novo Nordisk Investigational Site
New Windsor, New York, 12553
Novo Nordisk Investigational Site
North Massapequa, New York, 11758-1802
Novo Nordisk Investigational Site
Northport, New York, 11768
Novo Nordisk Investigational Site
Northridge, California, 91325
Novo Nordisk Investigational Site
Omaha, Nebraska, 68105
Novo Nordisk Investigational Site
Omaha, Nebraska, 68198-3020
Novo Nordisk Investigational Site
Paducah, Kentucky, 42003
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33027
Novo Nordisk Investigational Site
Peoria, Illinois, 61602
Novo Nordisk Investigational Site
Phoenix, Arizona, 85020
Novo Nordisk Investigational Site
Plano, Texas, 75075
Novo Nordisk Investigational Site
Plantation, Florida, 33324
Novo Nordisk Investigational Site
Port Orchard, Washington, 98366
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
San Diego, California, 92111
Novo Nordisk Investigational Site
San Ramon, California, 94583
Novo Nordisk Investigational Site
Spring Hill, Tennessee, 37174
Novo Nordisk Investigational Site
St Louis, Missouri, 63141
Novo Nordisk Investigational Site
Tampa, Florida, 33603
Novo Nordisk Investigational Site
Tempe, Arizona, 85283
Novo Nordisk Investigational Site
Toms River, New Jersey, 08755-8050
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Novo Nordisk Investigational Site
Troy, Michigan, 48085-5524
Novo Nordisk Investigational Site
Tullahoma, Tennessee, 37388
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Waterbury, Connecticut, 06708
Novo Nordisk Investigational Site
Wilmington, North Carolina, 28401

Other trials in United States

Canada13 sites

Novo Nordisk Investigational Site
Edmonton, Alberta, T5J 3N4
Novo Nordisk Investigational Site
Hamilton, Ontario, L8M 1K7
Novo Nordisk Investigational Site
Mirabel, Quebec, J7J 2K8
Novo Nordisk Investigational Site
Montreal, Quebec, H1Y 3L1
Novo Nordisk Investigational Site
Montreal, Quebec, H2R 1V6
Novo Nordisk Investigational Site
Mount Pearl, Newfoundland and Labrador, A1N 1W7
Novo Nordisk Investigational Site
Québec, G1G 3Y8
Novo Nordisk Investigational Site
Québec, G1N 4V3
Novo Nordisk Investigational Site
Saint Romuald, Quebec, G6W 5M6
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
Novo Nordisk Investigational Site
Surrey, British Columbia, V3S 2N6
Novo Nordisk Investigational Site
Thunder Bay, Ontario, P7B 7C7
Novo Nordisk Investigational Site
Waterloo, Ontario, N2J 1C4

Other trials in Canada

Russia12 sites

Novo Nordisk Investigational Site
Kursk, 305035
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 119435
Novo Nordisk Investigational Site
Moscow, 127644
Novo Nordisk Investigational Site
Penza, 440026
Novo Nordisk Investigational Site
Saint Petersburg, 191119
Novo Nordisk Investigational Site
Saint Petersburg, 194291
Novo Nordisk Investigational Site
Saint Petersburg, 194358
Novo Nordisk Investigational Site
Saint Petersburg, 195257
Novo Nordisk Investigational Site
Saint Petersburg, 199034
Novo Nordisk Investigational Site
Saint-Petesburg, 195257
Novo Nordisk Investigational Site
Stavropol, 355035

Other trials in Russia

India10 sites

Novo Nordisk Investigational Site
Bhubaneswar, Odisha, 751019
Novo Nordisk Investigational Site
Delhi, New Delhi, 110002
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500082
Novo Nordisk Investigational Site
Indore, Madhya Pradesh, 452010
Novo Nordisk Investigational Site
Jaipur, Rajasthan, 302006
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400008
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400012
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400058
Novo Nordisk Investigational Site
Pune, Maharashtra, 411004
Novo Nordisk Investigational Site
Pune, Maharashtra, 411040

Other trials in India

United Kingdom9 sites

Novo Nordisk Investigational Site
Epworth, DN9 1EP
Novo Nordisk Investigational Site
Hull, HU3 2RW
Novo Nordisk Investigational Site
Northampton, NN1 5BD
Novo Nordisk Investigational Site
Northwood, HA6 2RN
Novo Nordisk Investigational Site
Norwich, NR4 7TJ
Novo Nordisk Investigational Site
Nuneaton, CV10 7DJ
Novo Nordisk Investigational Site
Sidcup, DA14 6LT
Novo Nordisk Investigational Site
Stoke-on-Trent, ST4 6QG
Novo Nordisk Investigational Site
Wrexham, LL13 7TD

Other trials in United Kingdom

Croatia8 sites

Novo Nordisk Investigational Site
Čakovec, 40000
Novo Nordisk Investigational Site
Karlovac, 47000
Novo Nordisk Investigational Site
Osijek, 31 000
Novo Nordisk Investigational Site
Slavonski Brod, 35 000
Novo Nordisk Investigational Site
Split, 21 000
Novo Nordisk Investigational Site
Varaždin, 42 000
Novo Nordisk Investigational Site
Zagreb, 10 000
Novo Nordisk Investigational Site
Zagreb, 10000

Other trials in Croatia

Israel6 sites

Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Haifa, 35152
Novo Nordisk Investigational Site
Jerusalem, 91120
Novo Nordisk Investigational Site
Kfar Saba, 44281
Novo Nordisk Investigational Site
Rehovot, 76100
Novo Nordisk Investigational Site
Rishon LeZiyyon, 75650

Other trials in Israel

Slovakia5 sites

Novo Nordisk Investigational Site
Bratislava, 821 02
Novo Nordisk Investigational Site
Bratislava, 851 01
Novo Nordisk Investigational Site
Lučenec, 984 01
Novo Nordisk Investigational Site
Trnava, 91701
Novo Nordisk Investigational Site
Žilina, 01001

Other trials in Slovakia

Serbia3 sites

Novo Nordisk Investigational Site
Belgrade, 11000
Novo Nordisk Investigational Site
Niš, 18000
Novo Nordisk Investigational Site
Zaječar, 19000

Other trials in Serbia

Puerto Rico1 site

Novo Nordisk Investigational Site
Ponce, 00717

Other trials in Puerto Rico

About this study

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: Faster-acting insulin aspart, Insulin aspart, Insulin glargine
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Faster-acting insulin aspartDrug
Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Insulin aspartDrug
Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Insulin glargineDrug
Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.

Study groups in NCT01819129
Study group	Role	What they receive
Faster-acting insulin aspart (FIAsp)	Experimental	Meal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication. Receives: Drug: Faster-acting insulin aspart; Drug: Insulin glargine
Insulin aspart	Active comparator	Meal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication. Receives: Drug: Insulin aspart; Drug: Insulin glargine

What is being measured

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

Change From Baseline in HbA1c
The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Measured: Week 0, Week 26

Secondary outcomes (3)

Change From Baseline in 2-hour PPG Increment (Meal Test)
For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Measured: Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
A hypoglycaemic episode was defined as treatment-emergent if the onset of the episode was on or after the first day of exposure to randomized treatment and no later than 1 day after the last day of randomized treatment. A severe or blood glucose (BG) confirmed hypoglycaemic episode was an episode that was severe according to the American Diabetes Association (ADA) classification (an episode that required assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.
Measured: From Week 0 to Week 26.
Change From Baseline in Body Weight
For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.
Measured: Week 0, week 26

Timeline

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

9 Sep 201322 Jan 2015

First posted27 Mar 2013 (estimated)
Study start9 Sep 2013
Primary completion22 Jan 2015
Study completion22 Jan 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 (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: 881 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01819129
Sponsor's protocol ID: NN1218-3853
Other IDs: 2010-024051-93, U1111-1118-2509, CTRI/2014/01/004285
Acronym: onset® 2
Status last verified: Jan 2019
First submitted: 21 Mar 2013
Last updated: 30 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7):951-957. doi: 10.2337/dc16-1770. Epub 2017 May 8.
PubMed 28483786
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
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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 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 in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01819129
Acronym / sponsor ID: onset® 2 / NN1218-3853
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 881 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 9 Sep 2013 (actual)
Primary completion: 22 Jan 2015 (actual)
Study completion: 22 Jan 2015 (actual)
First posted: 27 Mar 2013 (estimated)
Results: Posted 5 Dec 2017

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: 2

Arm	Type	Receives
Faster-acting insulin aspart (FIAsp)	Experimental	Drug: Faster-acting insulin aspart, Drug: Insulin glargineMeal time faster-acting insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.
Insulin aspart	Active comparator	Drug: Insulin aspart, Drug: Insulin glargineMeal time insulin aspart is given in combination with once daily insulin glargine and metformin in a basal-bolus regimen. Insulin glargine and metformin treatment are open labelled background medication.

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 aspartMealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.	Drug	Faster-acting insulin aspart (FIAsp)
Insulin aspartMealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.	Drug	Insulin aspart
Insulin glargineAdministered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.	Drug	Faster-acting insulin aspart (FIAsp), Insulin aspart

Primary outcome

Change From Baseline in HbA1c
Time frame: Week 0, Week 26
The primary endpoint was change from baseline in HbA1c after 26 weeks of randomized treatment. For this endpoint baseline (week 0) and week 26 have been presented, where week 26 data is end of trial containing last available measurement.

3 secondary outcomes

Change From Baseline in 2-hour PPG Increment (Meal Test)
Time frame: Week 0, week 26
Number of Treatment Emergent Confirmed Hypoglycaemic Episodes
Time frame: From Week 0 to Week 26.
Change From Baseline in Body Weight
Time frame: Week 0, week 26

Results and safety

Results posted to the registry on 5 Dec 2017, 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	345	301
NovoRapid	344	305

Primary outcome: Change From Baseline in HbA1c

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

Measure	Faster Aspart n = 345	NovoRapid n = 344
Baseline (week 0)	7.96 (0.68)	7.89 (0.71)
Week 26	6.63 (0.88)	6.59 (0.84)

Faster Aspart vs NovoRapid: Mean Difference (Net): -0.02 (95% CI -0.15 to 0.10)

Population analysed: The analysis of this efficacy endpoint was based on the full analysis set (FAS). FAS included all randomized subjects. The statistical evaluation of the FAS was to follow the intention-to-treat (ITT) principle and subjects contributed to the evaluation 'as randomized'.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: All treatment-emergent adverse events (AEs) were collected from the date on or after the first day of exposure to randomized treatment until no later than 7 days after the last day of randomised treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Faster Aspart	15 of 341 (4.4%)	49 of 341 (14.4%)	Not reported
NovoRapid	24 of 341 (7%)	53 of 341 (15.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28483786Bowering K, Case C, Harvey J, Reeves M, Sampson M, Strzinek R, Bretler DM, Bang RB, Bode BW. Faster Aspart Versus Insulin Aspart as Part of a Basal-Bolus Regimen in Inadequately Controlled Type 2 Diabetes: The onset 2 Trial. Diabetes Care. 2017 Jul;40(7):951-957. doi: 10.2337/dc16-1770. Epub 2017 May 8.
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 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

144 sites in 10 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 aspart and Insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 144 sites in 10 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 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 144 sites in United States, Canada, Russia, India, United Kingdom and 5 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 5 Dec 2017). 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 (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 NCT01819129, 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 30 Jan 2019.