DiabetesPhase 3BOOST™NCT01045707

Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes

A Phase 3 study testing insulin degludec/insulin aspart and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 92 sites in 9 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 the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN5401 (insulin degludec/insulin aspart (IDegAsp)) with insulin glargine (IGlar), both as add-on to subject's ongoing treatment with metformin + at least one OAD (oral… 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 and insulin glargine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 530 participants
Where: 92 sitesin 9 countries
Study dates: Jan 2010to Oct 2010
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

For MAIN period (NN5401-3590):
Diagnosis of type 2 diabetes mellitus for at least 6 months
Insulin naïve subjects
Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)
Body Mass Index (BMI) no higher than 40.0 kg/m^2

Show all 9Show fewer

For EXTENSION period (NN5401-3726):
Informed consent obtained before any trial-related activities
Must have completed the 26-week treatment period (visit 28) in trial NN5401-3590

Who cannot join

For MAIN period (NN5401-3590):
Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Cardiovascular disease diagnosed within 6 months before trial start
For EXTENSION period (NN5401-3726):
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors
Anticipated significant lifestyle changes during the trial, e.g. shift work (including permanent night/evening shift workers), as well as highly variable eating habits as judged by the physician)
Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements

Trial locations and contacts

92 sites in 9 countries.

Country

City, postcode or hospital

92 sites in 9 countries

United States41 sites

Novo Nordisk Investigational Site
Birmingham, Alabama, 35233
Novo Nordisk Investigational Site
Brooklyn, New York, 11203
Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37404
Novo Nordisk Investigational Site
Concord, California, 94520-1926
Novo Nordisk Investigational Site
Council Bluffs, Iowa, 51501
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75235
Novo Nordisk Investigational Site
Detroit, Michigan, 48235
Novo Nordisk Investigational Site
Greenbrae, California, 94904
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Greenville, North Carolina, 27834
Novo Nordisk Investigational Site
Greer, South Carolina, 29651
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96813
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Los Angeles, California, 90057
Novo Nordisk Investigational Site
Lubbock, Texas, 79423
Novo Nordisk Investigational Site
Memphis, Tennessee, 38119
Novo Nordisk Investigational Site
Metairie, Louisiana, 70006-2930
Novo Nordisk Investigational Site
Miami, Florida, 33135
Novo Nordisk Investigational Site
Miami, Florida, 33136
Novo Nordisk Investigational Site
Miami, Florida, 33169
Novo Nordisk Investigational Site
Morehead City, North Carolina, 28557
Novo Nordisk Investigational Site
New Orleans, Louisiana, 70119
Novo Nordisk Investigational Site
Newport News, Virginia, 23606
Novo Nordisk Investigational Site
North Miami, Florida, 33161
Novo Nordisk Investigational Site
Olympia, Washington, 98502
Novo Nordisk Investigational Site
Pembroke Pines, Florida, 33027
Novo Nordisk Investigational Site
Portland, Oregon, 97220
Novo Nordisk Investigational Site
Portland, Oregon, 97239
Novo Nordisk Investigational Site
Saint Charles, Missouri, 63303
Novo Nordisk Investigational Site
San Antonio, Texas, 78240
Novo Nordisk Investigational Site
Smithtown, New York, 11787
Novo Nordisk Investigational Site
Springfield, Missouri, 65807
Novo Nordisk Investigational Site
St. George, Utah, 84790
Novo Nordisk Investigational Site
Tomball, Texas, 77375
Novo Nordisk Investigational Site
Troy, Michigan, 48085-5524
Novo Nordisk Investigational Site
Tulsa, Oklahoma, 74104
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, 35209
Novo Nordisk Investigational Site
Waterbury, Connecticut, 06708
Novo Nordisk Investigational Site
Wilson, North Carolina, 27893

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Spain11 sites

Novo Nordisk Investigational Site
Barcelona, 08035
Novo Nordisk Investigational Site
Málaga, 29006
Novo Nordisk Investigational Site
Mérida, 06800
Novo Nordisk Investigational Site
Palma de Mallorca, 07198
Novo Nordisk Investigational Site
Partida de Bacarot, 03114
Novo Nordisk Investigational Site
Pozuelo de Alarcón, 28223
Novo Nordisk Investigational Site
San Sebastián de los Reyes, 28700
Novo Nordisk Investigational Site
Santiago de Compostela, 15706
Novo Nordisk Investigational Site
Seville, 41009
Novo Nordisk Investigational Site
Valencia, 46014
Novo Nordisk Investigational Site
Valladolid, 47005

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Russia10 sites

Novo Nordisk Investigational Site
Arkhangelsk, 163045
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Nizhny Novgorod, 603126
Novo Nordisk Investigational Site
Orenburg, 460040
Novo Nordisk Investigational Site
Samara, 443067
Novo Nordisk Investigational Site
Saratov, 410053
Novo Nordisk Investigational Site
Saratov, 410710
Novo Nordisk Investigational Site
Smolensk, 214019
Novo Nordisk Investigational Site
Stavropol, 355017
Novo Nordisk Investigational Site
Yaroslavl, 150003

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Austria6 sites

Novo Nordisk Investigational Site
Ebreichsdorf, 2483
Novo Nordisk Investigational Site
Feldbach, 8330
Novo Nordisk Investigational Site
Innsbruck, 6020
Novo Nordisk Investigational Site
Salzburg, 5010
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, 1060

Other trials in Austria

India6 sites

Novo Nordisk Investigational Site
Bangalore, 560038
Novo Nordisk Investigational Site
Jaipur, Rajasthan, 302006
Novo Nordisk Investigational Site
Kerala, 682026
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400053
Novo Nordisk Investigational Site
Patna, 800020
Novo Nordisk Investigational Site
Trichy, Tamil Nadu, 620018

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Poland6 sites

Novo Nordisk Investigational Site
Krakow, 31-261
Novo Nordisk Investigational Site
Lodz, 90-003
Novo Nordisk Investigational Site
Lodz, 93-338
Novo Nordisk Investigational Site
Lublin, 20-044
Novo Nordisk Investigational Site
Pruszków, 05-800
Novo Nordisk Investigational Site
Warsaw, 02-507

Other trials in Poland

Turkey (Türkiye)6 sites

Novo Nordisk Investigational Site
Antalya, 07058
Novo Nordisk Investigational Site
Istanbul, 34096
Novo Nordisk Investigational Site
Istanbul, 34390
Novo Nordisk Investigational Site
Istanbul, 34400
Novo Nordisk Investigational Site
Istanbul, 34760
Novo Nordisk Investigational Site
Istanbul

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South Korea5 sites

Novo Nordisk Investigational Site
Pucheon, 424-017
Novo Nordisk Investigational Site
Pusan, 602-739
Novo Nordisk Investigational Site
Seoul, 08308
Novo Nordisk Investigational Site
Seoul, 137-701
Novo Nordisk Investigational Site
Seoul, 158-710

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Puerto Rico1 site

Novo Nordisk Investigational Site
Bayamón, 00961

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About this study

Official title: NN5401-3590: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes (BOOST™: START 1)

The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec/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.

insulin degludec/insulin aspartDrug
Injected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.
insulin glargineDrug
Injected s.c. (under the skin) once daily. Dose was individually adjusted.

Study groups in NCT01045707
Study group	Role	What they receive
IDegAsp OD	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart
IGlar OD	Experimental	Not described Receives: Drug: insulin glargine

What is being measured

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

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Change from baseline in HbA1c after 26 weeks of treatment.
Measured: Week 0, Week 26
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Measured: Week 0 to Week 53 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Measured: Week 0 to Week 53 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect
Measured: Week 0 to Week 53 + 7 days follow up

Secondary outcomes (2)

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Change from baseline in HbA1c after 52 weeks of treatment.
Measured: Week 0, Week 53
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Mean of SMPG at 26 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Measured: Week 26

Timeline

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

Jan 2010Oct 2010

First posted11 Jan 2010 (estimated)
Study startJan 2010
Primary completionOct 2010
Study completionOct 2010

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 (2)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: None (open label)
Enrolment: 530 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01045707
Sponsor's protocol ID: NN5401-3590
Other IDs: 2009-011271-78, U1111-1111-7178, 2009-015839-33, U1111-1114-9237, 2009
Acronym: BOOST™
Status last verified: Oct 2016
First submitted: 8 Jan 2010
Last updated: 8 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Kumar A, Franek E, Wise J, Niemeyer M, Mersebach H, Simo R. Efficacy and Safety of Once-Daily Insulin Degludec/Insulin Aspart versus Insulin Glargine (U100) for 52 Weeks in Insulin-Naive Patients with Type 2 Diabetes: A Randomized Controlled Trial. PLoS One. 2016 Oct 19;11(10):e0163350. doi: 10.1371/journal.pone.0163350. eCollection 2016.
PubMed 27760129
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

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 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NN5401-3590: A Trial Comparing Efficacy and Safety of NN5401 With Insulin Glargine in Insulin Naive Subjects With Type 2 Diabetes (BOOST™ : START 1) / NN5401-3726: An Extension Trial Comparing Safety and Efficacy of NN5401 With Insulin Glargine in Subjects With Type 2 Diabetes (BOOST™: START 1)
ClinicalTrials.gov ID: NCT01045707
Acronym / sponsor ID: BOOST™ / NN5401-3590
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 530 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 11 Jan 2010 (estimated)
Results: Posted 20 Nov 2015

Clinical summary

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

The main period is registered internally at Novo Nordisk as NN5401-3590 while the extension period is registered as NN5401-3726.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
IDegAsp OD	Experimental	Drug: insulin degludec/insulin aspart
IGlar OD	Experimental	Drug: insulin glargine

Who may qualify

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

Key inclusion criteria (9 listed)

For MAIN period (NN5401-3590):
Diagnosis of type 2 diabetes mellitus for at least 6 months
Insulin naïve subjects
Treatment with metformin and at least one other oral antidiabetic drug for at least 3 months before trial start
Glycosylated haemoglobin (HbA1c) between 7.5 - 11.0% (both inclusive)

Key exclusion criteria (7 listed)

For MAIN period (NN5401-3590):
Treatment with glucagon like peptide-1 (GLP-1) receptor agonists and/or thiazolidinedione(s) within the last 3 months prior to trial start
Cardiovascular disease diagnosed within 6 months before trial start
For EXTENSION period (NN5401-3726):
Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, Monoamine oxidase (MAO) inhibitors

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
insulin degludec/insulin aspartInjected s.c. (under the skin) once daily with the breakfast meal. Dose was individually adjusted.	Drug	IDegAsp OD
insulin glargineInjected s.c. (under the skin) once daily. Dose was individually adjusted.	Drug	IGlar OD

Primary outcome

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Time frame: Week 0, Week 26
Change from baseline in HbA1c after 26 weeks of treatment.
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 53 + 7 days follow up
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Time frame: Week 0 to Week 53 + 7 days follow up
Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Time frame: Week 0 to Week 53 + 7 days follow up
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect

2 secondary outcomes

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Time frame: Week 0, Week 53
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
Time frame: Week 26

Results and safety

Results posted to the registry on 20 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IDegAsp OD	266	219
IGlar OD	264	232

Primary outcome: Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

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

Measure	IDegAsp OD n = 266	IGlar OD n = 263
Value	-1.65 (1.28)	-1.72 (1.17)

Population analysed: The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.

Primary outcome: Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

Time frame: Week 0 to Week 53 + 7 days follow up. Number. Unit: Episodes/100 years of patient exposure

Measure	IDegAsp OD n = 265	IGlar OD n = 261
Value	419	211

Population analysed: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Primary outcome: Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

Time frame: Week 0 to Week 53 + 7 days follow up. Number. Unit: Episodes/100 years of patient exposure

Measure	IDegAsp OD n = 265	IGlar OD n = 261
Value	19	53

Population analysed: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Primary outcome: Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Time frame: Week 0 to Week 53 + 7 days follow up. Number. Unit: Events/100 years of patient exposure

Measure	IDegAsp OD n = 265	IGlar OD n = 261
Adverse events (AE)	313	238
Serious AE	17	9
Severe AE	9	10
Moderate AE	77	66
Mild AE	227	162
Fatal AE	2	1

Population analysed: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Week 0 to Week 53 + 7 days follow up.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDegAsp OD	30 of 265 (11.3%)	88 of 265 (33.2%)	Not reported
IGlar OD	15 of 261 (5.7%)	79 of 261 (30.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 27760129Kumar A, Franek E, Wise J, Niemeyer M, Mersebach H, Simo R. Efficacy and Safety of Once-Daily Insulin Degludec/Insulin Aspart versus Insulin Glargine (U100) for 52 Weeks in Insulin-Naive Patients with Type 2 Diabetes: A Randomized Controlled Trial. PLoS One. 2016 Oct 19;11(10):e0163350. doi: 10.1371/journal.pone.0163350. eCollection 2016.
Derived from this study: PubMed 35044568Yang 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.
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 insulin degludec/insulin aspart and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, 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 9 inclusion and 7 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 8 Dec 2016. 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, Spain, Russia, Austria, India 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 20 Nov 2015). 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?

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment (time frame: Week 0, Week 26). The study lists 4 primary outcomes in all. 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 NCT01045707, 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 8 Dec 2016.