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DiabetesPhase 3NCT02906917

A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification

A Phase 3 study testing Insulin degludec/insulin aspart, Insulin glargine and Insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 71 sites in 7 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

Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification. 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?
Insulin degludec/insulin aspart, Insulin glargine and Insulin aspart
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
532 participants
Where
71 sitesin 7 countries
Study dates
20 Sep 2016to 24 Dec 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

  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
  • Male or female, age at least 18 years at the time of signing informed consent Algeria: Male or female, age at least 19 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes mellitus
  • Treated with any basal insulin for at least 90 days prior to the day of screening
  • Subject not on any OAD(s) prior to trial participation OR subjects on stable daily dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s) include any of the following anti-diabetic drug s)/regimen: a. Biguanides (metformin at least 1500 mg or maximum tolerated dose documented in the subject medical record) b. Other OADs (at least half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record): i. Insulin secretagogues (SU and glinides) ii. Di-peptidyl-peptidase IV (DPP-4) inhibitors iii. α-glucosidase inhibitors iv. Sodium/glucose co-transporter 2 (SGLT-2) inhibitors v. Oral combination products (of the allowed individual OADs above)
  • HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis
  • Body mass index (BMI) equal to or below 45.0 kg/m^2

Who cannot join

  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within four weeks prior to the day of screening (V1)
  • Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
  • Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) equal or below 90 days prior to the day of the screening and between screening and randomisation
  • Any of the following: myocardial infarction, stroke or hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and between screening and randomisation
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 60 ml/min/1.73 m^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening
  • Impaired liver function, defined as alanine aminotransferase (ALT) equal to or above 2.5 times upper normal limit (UNL) at screening.
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  • Subjects presently classified as being in New York Heart Association (NYHA) Class IV
  • Planned coronary, carotid or peripheral artery revascularisation known on 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 the day of screening
  • Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids)

Trial locations and contacts

71 sites in 7 countries.

71 sites in 7 countries

United States30 sites

  • Novo Nordisk Investigational Site

    Anaheim, California, 92801

  • Novo Nordisk Investigational Site

    Austin, Texas, 78758

  • Novo Nordisk Investigational Site

    Bartlett, Tennessee, 38133

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37411

  • Novo Nordisk Investigational Site

    Chesapeake, Virginia, 23321

  • Novo Nordisk Investigational Site

    Chesterfield, Missouri, 63017

  • Novo Nordisk Investigational Site

    Concord, California, 94520

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75390-9302

  • Novo Nordisk Investigational Site

    Danbury, Connecticut, 06810

  • Novo Nordisk Investigational Site

    Fort Lauderdale, Florida, 33312

  • 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

    Glendale, Arizona, 85306-4652

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32205

  • Novo Nordisk Investigational Site

    Kingsport, Tennessee, 37660

  • Novo Nordisk Investigational Site

    Kissimmee, Florida, 34744

  • Novo Nordisk Investigational Site

    Knoxville, Tennessee, 37938

  • Novo Nordisk Investigational Site

    La Jolla, California, 92037

  • Novo Nordisk Investigational Site

    Louisville, Kentucky, 40213

  • Novo Nordisk Investigational Site

    Midlothian, Virginia, 23114

  • Novo Nordisk Investigational Site

    Nashville, Tennessee, 37228

  • Novo Nordisk Investigational Site

    New York, New York, 10029

  • Novo Nordisk Investigational Site

    Northridge, California, 91325

  • Novo Nordisk Investigational Site

    Phoenix, Arizona, 85050

  • Novo Nordisk Investigational Site

    Roswell, Georgia, 30076

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78230

  • Novo Nordisk Investigational Site

    Westfield, New York, 14787

  • Novo Nordisk Investigational Site

    Wilmington, North Carolina, 28401

  • Novo Nordisk Investigational Site

    Winchester, Virginia, 22601-3834

Other trials in United States

Russia11 sites

  • Novo Nordisk Investigational Site

    Arkhangelsk, 163045

  • Novo Nordisk Investigational Site

    Cheboksary, 428009

  • Novo Nordisk Investigational Site

    Moscow, 127486

  • Novo Nordisk Investigational Site

    Saint Petersburg, 191119

  • Novo Nordisk Investigational Site

    Saint Petersburg, 194354

  • Novo Nordisk Investigational Site

    Saint Petersburg, 195213

  • Novo Nordisk Investigational Site

    Saint Petersburg, 197762

  • Novo Nordisk Investigational Site

    Saratov, 410039

  • Novo Nordisk Investigational Site

    Saratov, 410053

  • Novo Nordisk Investigational Site

    Syktyvkar, 167981

  • Novo Nordisk Investigational Site

    Tyumen, 625023

Other trials in Russia

India10 sites

  • Novo Nordisk Investigational Site

    Chhatrapati Sambhajinagar, Maharashtra, 431005

  • Novo Nordisk Investigational Site

    Coimbatore, Tamil Nadu, 641018

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh, 500001

  • Novo Nordisk Investigational Site

    Hyderabad, Andhra Pradesh, 500072

  • Novo Nordisk Investigational Site

    Kolkata, West Bengal, 700054

  • Novo Nordisk Investigational Site

    Kozhikode, Kerala, 673017

  • Novo Nordisk Investigational Site

    Mumbai, Maharashtra, 400058

  • Novo Nordisk Investigational Site

    New Dehli, New Delhi, 110029

  • Novo Nordisk Investigational Site

    New Delhi, 110001

  • Novo Nordisk Investigational Site

    Surat, Gujarat, 395002

Other trials in India

Turkey (Türkiye)8 sites

  • Novo Nordisk Investigational Site

    Adana, 01250

  • Novo Nordisk Investigational Site

    Ankara, 06100

  • Novo Nordisk Investigational Site

    Ankara, 06500

  • Novo Nordisk Investigational Site

    Istanbul, 34098

  • Novo Nordisk Investigational Site

    Istanbul, 34303

  • Novo Nordisk Investigational Site

    Istanbul, 34718

  • Novo Nordisk Investigational Site

    Istanbul, 34752

  • Novo Nordisk Investigational Site

    Izmir, 35340

Other trials in Turkey (Türkiye)

Czechia6 sites

  • Novo Nordisk Investigational Site

    Broumov, 550 01

  • Novo Nordisk Investigational Site

    Náchod, 547 01

  • Novo Nordisk Investigational Site

    Náchod, 54701

  • Novo Nordisk Investigational Site

    Prague, 140 21

  • Novo Nordisk Investigational Site

    Prague, 140 46

  • Novo Nordisk Investigational Site

    Trutnov, 541 01

Other trials in Czechia

Algeria3 sites

  • Novo Nordisk Investigational Site

    Constantine, 25000

  • Novo Nordisk Investigational Site

    Oran, 31000

  • Novo Nordisk Investigational Site

    Sidi Bel Abbes, 22000

Other trials in Algeria

Serbia3 sites

  • Novo Nordisk Investigational Site

    Belgrade, 11000

  • Novo Nordisk Investigational Site

    Belgrade, 11080

  • Novo Nordisk Investigational Site

    Niš, 18000

Other trials in Serbia

About this study

Official title: This Trial is Conducted Globally. The Aim of This Trial is to Compare the Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification.

Trial comparing effect and safety of insulin degludec/insulin aspart vs. insulin glargine plus insulin aspart in subjects with type 2 diabetes treated with basal insulin with or without oral antidiabetic treatment in need of treatment intensification.

Being tested
Insulin degludec/insulin aspart, Insulin glargine, Insulin aspart
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.

  • Insulin degludec/insulin aspartDrug

    Administered subcutaneously (s.c. under the skin) once daily.

  • Insulin glargineDrug

    Administered subcutaneously (s.c. under the skin) once daily.

  • Insulin aspartDrug

    Administered subcutaneously (s.c. under the skin) once daily.

Study groups in NCT02906917
Study groupRoleWhat they receive
IDegAspExperimentalNot described
Receives: Drug: Insulin degludec/insulin aspart
IGlar + IAspActive comparatorNot described
Receives: Drug: Insulin glargine; Drug: Insulin aspart

What is being measured

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

  1. Change in HbA1c (%) - Week 26

    Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated 26 weeks after randomisation.

    Measured: Week 0, week 26

Secondary outcomes (11)

  1. Change in HbA1c (%) - Week 38

    Change from baseline (week 0) in HbA1c was evaluated 38 weeks after randomisation.

    Measured: Week 0, week 38

  2. Responder (Yes/No) for HbA1c < 7%

    Participants achieving (yes/no) HbA1c <7% was evaluated 26 and 38 weeks after randomisation, respectively.

    Measured: Week 26 and week 38

  3. Responder (Yes/No) for HbA1c <7% Without Severe or BG Confirmed Symptomatic Hypoglycaemia

    Participants achieving (yes/no) HbA1c <7% without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia, was evaluated 26 and 38 weeks after randomisation, respectively. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA classification: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

    Measured: Week 26 and week 38

  4. Change in FPG

    Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated 26 and 38 weeks after randomisation, respectively.

    Measured: Week 0, week 26, week 38

  5. Change in Pre-breakfast SMPG (Used for Titration)

    Reported results are observed pre-breakfast self-measured plasma glucose (SMPG; used for titration) values at week 1 (baseline) and 26 and 38 weeks after randomisation.

    Measured: Week 1, week 26, week 38

  6. Change in Postprandial SMPG Increment (From 9-point Profile)

    Change from baseline (week 0) in postprandial SMPG increment (from 9-point profile) was evaluated 26 and 38 weeks after randomisation, respectively. 9-point SMPG profiles were measured starting in the morning 2 days prior to the scheduled visit at the time points described below: 1) Before breakfast (2 days prior to visit) 2) 90 minutes after start of the breakfast 3) Before lunch 4) 90 minutes after start of the lunch 5) Before dinner/main evening meal 6) 90 minutes after start of the dinner/main evening meal 7) At bedtime (2 days or 1 day prior to visit depending on actual clock time) 8) At 4 a.m. (1 day prior to visit) 9) Before breakfast at the following day (1 day prior to the visit).

    Measured: Week 0, week 26, week 38

  7. Number of Nocturnal, Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

    Number of nocturnal, treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Nocturnal hypoglycaemic episodes: episodes occurring between 00:01 and 05:59 both inclusive. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.

    Measured: Weeks 0-26, weeks 16-26, weeks 0-38

  8. Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

    Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were analysed during the following periods: weeks 0-26, weeks 16-26 and weeks 0-38. Treatment emergent: hypoglycaemic episodes were defined as treatment emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product.

    Measured: Weeks 0-26, weeks 16-26, weeks 0-38

  9. Total Insulin Dose

    Total insulin dose was evaluated 26 and 38 weeks after randomisation, respectively.

    Measured: Week 26 and week 38

  10. Change in Body Weight

    Change from baseline (week 0) in body weight was evaluated 26 and 38 weeks after randomisation, respectively.

    Measured: Week 0, week 26, week 38

  11. Incidence of TEAEs

    Number of treatment emergent adverse events (TEAEs) were analysed during the following periods: weeks 0-26, weeks 26-38 and weeks 0-38. Treatment emergent: An adverse 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. If an event had an onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period, or if it had an onset date within 7 days after the last drug date, then this event was also to be considered as a TEAE.

    Measured: Weeks 0-26, weeks 26-38, weeks 0-38

Timeline

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

  1. First posted20 Sep 2016 (estimated)
  2. Study start20 Sep 2016
  3. Primary completion31 Aug 2017
  4. Study completion24 Dec 2017

Resources

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
None (open label)
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02906917
Sponsor's protocol ID
NN5401-4266
Other IDs
2015-004768-12, U1111-1175-7895, 2015
Status last verified
Nov 2019
First submitted
15 Sep 2016
Last updated
13 Nov 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Philis-Tsimikas A, Astamirova K, Gupta Y, Haggag A, Roula D, Bak BA, Fita EG, Nielsen AM, Demir T. Similar glycaemic control with less nocturnal hypoglycaemia in a 38-week trial comparing the IDegAsp co-formulation with insulin glargine U100 and insulin aspart in basal insulin-treated subjects with type 2 diabetes mellitus. Diabetes Res Clin Pract. 2019 Jan;147:157-165. doi: 10.1016/j.diabres.2018.10.024. Epub 2018 Nov 16.

    PubMed 30448451

  • Yang W, Akhtar S, Franek E, Haluzik M, Hirose T, Kalyanam B, Kar S, Wu T, Gogas Yavuz D, Unnikrishnan AG. Postprandial Glucose Excursions in Asian Versus Non-Asian Patients with Type 2 Diabetes: A Post Hoc Analysis of Baseline Data from Phase 3 Randomised Controlled Trials of IDegAsp. Diabetes Ther. 2022 Feb;13(2):311-323. doi: 10.1007/s13300-021-01196-7. Epub 2022 Jan 19.

    PubMed 35044568

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin degludec/insulin aspart, Insulin glargine and Insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 71 sites in 7 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 7 inclusion and 10 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 13 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 71 sites in United States, Russia, India, Turkey (Türkiye), Czechia and 2 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 28 Sep 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 HbA1c (%) - Week 26 (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 NCT02906917, which also lists 2 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 13 Nov 2019.

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