DiabetesPhase 3NCT01713530

A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin

A Phase 3 study testing insulin degludec/insulin aspart, insulin degludec and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 51 sites in 5 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 Africa, Europe and the United States of America (USA). The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart… 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 degludec and insulin aspart
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 274 participants
Where: 51 sitesin 5 countries
Study dates: 21 Feb 2013to 9 Jan 2014
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

Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
HbA1c 7.0% - 10.0%
Body mass index (BMI) less than or equal to 40.0 kg/m^2

Who cannot join

Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Chronic disorder or disease which might jeopardise safety or compliance
Malignant neoplasms
Recurrent severe hypoglycaemia

Trial locations and contacts

51 sites in 5 countries.

Country

City, postcode or hospital

51 sites in 5 countries

United States26 sites

Novo Nordisk Investigational Site
Austin, Texas, 78731
Novo Nordisk Investigational Site
Buckley, Michigan, 49620
Novo Nordisk Investigational Site
Chicago, Illinois, 60607
Novo Nordisk Investigational Site
Dallas, Texas, 75230
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Greenbrae, California, 94904
Novo Nordisk Investigational Site
Greensboro, North Carolina, 27408
Novo Nordisk Investigational Site
Hillsborough, New Jersey, 08844-1225
Novo Nordisk Investigational Site
Houston, Texas, 77024
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46254
Novo Nordisk Investigational Site
Kettering, Ohio, 45429
Novo Nordisk Investigational Site
Kingsport, Tennessee, 37660
Novo Nordisk Investigational Site
Kissimmee, Florida, 34741
Novo Nordisk Investigational Site
Lawrenceville, New Jersey, 08648
Novo Nordisk Investigational Site
Martinsburg, West Virginia, 25401
Novo Nordisk Investigational Site
Mission Hills, California, 91345
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15236
Novo Nordisk Investigational Site
Rockville, Maryland, 20852
Novo Nordisk Investigational Site
Round Rock, Texas, 78681
Novo Nordisk Investigational Site
San Antonio, Texas, 78224
Novo Nordisk Investigational Site
San Diego, California, 92111
Novo Nordisk Investigational Site
Slidell, Louisiana, 70461-4231
Novo Nordisk Investigational Site
Tacoma, Washington, 98405
Novo Nordisk Investigational Site
Toms River, New Jersey, 08755-8050
Novo Nordisk Investigational Site
Wadsworth, Ohio, 44281-9236
Novo Nordisk Investigational Site
Whiteville, North Carolina, 28472

Other trials in United States

France8 sites

Novo Nordisk Investigational Site
Caen, 14033
Novo Nordisk Investigational Site
La Roche-sur-Yon, 85295
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Montpellier, 34000
Novo Nordisk Investigational Site
Montpellier, 34070
Novo Nordisk Investigational Site
Saint-Herblain, 44800
Novo Nordisk Investigational Site
Vénissieux, 69200

Other trials in France

Austria7 sites

Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Innsbruck, 6020
Novo Nordisk Investigational Site
Linz, 4021
Novo Nordisk Investigational Site
Mödling, 2340
Novo Nordisk Investigational Site
Salzburg, 5010
Novo Nordisk Investigational Site
Vienna, 1090
Novo Nordisk Investigational Site
Vienna, 1130

Other trials in Austria

Norway6 sites

Novo Nordisk Investigational Site
Hamar, 2317
Novo Nordisk Investigational Site
Kongsvinger, 2212
Novo Nordisk Investigational Site
Kristiansand, 4604
Novo Nordisk Investigational Site
Oslo, 0586
Novo Nordisk Investigational Site
Skedsmokorset, NO-2020
Novo Nordisk Investigational Site
Stavanger, 4011

Other trials in Norway

Algeria4 sites

Novo Nordisk Investigational Site
Algiers
Novo Nordisk Investigational Site
Annaba
Novo Nordisk Investigational Site
Constantine, 25000
Novo Nordisk Investigational Site
Oran, 31000

Other trials in Algeria

About this study

This trial is conducted in Africa, Europe and the United States of America (USA).

The aim of the trial is to compare the difference in change in glycosylated haemoglobin (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin degludec/insulin aspart, insulin degludec, 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
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
insulin degludecDrug
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
insulin aspartDrug
Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.

Study groups in NCT01713530
Study group	Role	What they receive
IDegAsp BID+/-OADs	Experimental	Not described Receives: Drug: insulin degludec/insulin aspart
IDeg OD plus IAsp +/-OADs	Experimental	Not described Receives: Drug: insulin degludec; Drug: insulin aspart

What is being measured

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

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

Secondary outcomes (5)

Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in FPG after 26 weeks of treatment
Measured: Week 0, week 26
Number of Treatment Emergent Hypoglycaemic Episodes
According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL))
Measured: During Weeks 0-26
Number of Treatment Emergent Hypoglycaemic Episodes
According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes:
Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia
Measured: During Weeks 0-26
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Measured: Weeks 0-26
Incidence of Treatment Emergent Adverse Events (TEAE)
A TEAE was defined as an event that has 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: Weeks 0-26

Timeline

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

21 Feb 20139 Jan 2014

First posted24 Oct 2012 (estimated)
Study start21 Feb 2013
Primary completion9 Jan 2014
Study completion9 Jan 2014

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: None (open label)
Enrolment: 274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01713530
Sponsor's protocol ID: NN5401-3996
Other IDs: 2012-002346-20, U1111-1130-7135
Status last verified: Mar 2018
First submitted: 22 Oct 2012
Last updated: 2 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rodbard HW, Cariou B, Pieber TR, Endahl LA, Zacho J, Cooper JG. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab. 2016 Mar;18(3):274-80. doi: 10.1111/dom.12609. Epub 2016 Jan 11.
PubMed 26592732
Haluzik M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25.
PubMed 29451706
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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
ClinicalTrials.gov ID: NCT01713530
Acronym / sponsor ID: NN5401-3996
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 274 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: 21 Feb 2013 (actual)
Primary completion: 9 Jan 2014 (actual)
Study completion: 9 Jan 2014 (actual)
First posted: 24 Oct 2012 (estimated)
Results: Posted 17 Nov 2015

Clinical summary

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

This trial is conducted in Africa, Europe and the United States of America (USA).

Study design

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

Arm	Type	Receives
IDegAsp BID+/-OADs	Experimental	Drug: insulin degludec/insulin aspart
IDeg OD plus IAsp +/-OADs	Experimental	Drug: insulin degludec, Drug: insulin aspart

Who may qualify

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

Key inclusion criteria (4 listed)

Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at least 26 weeks prior to screening (visit 1)
Treatment with basal insulin for at least 12 weeks prior to randomisation with or without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors, alfa-glucosidase-inhibitors
HbA1c 7.0% - 10.0%
Body mass index (BMI) less than or equal to 40.0 kg/m^2

Key exclusion criteria (5 listed)

Treatment with glucose-lowering agent(s) other than those stated in the inclusion criteria
Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty
Chronic disorder or disease which might jeopardise safety or compliance
Malignant neoplasms
Recurrent severe hypoglycaemia

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 aspartDose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.	Drug	IDegAsp BID+/-OADs
insulin degludecDose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.	Drug	IDeg OD plus IAsp +/-OADs
insulin aspartDose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.	Drug	IDeg OD plus IAsp +/-OADs

Primary outcome

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

5 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Week 0, week 26
Number of Treatment Emergent Hypoglycaemic Episodes
Time frame: During Weeks 0-26
Number of Treatment Emergent Hypoglycaemic Episodes
Time frame: During Weeks 0-26
Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes
Time frame: Weeks 0-26
Incidence of Treatment Emergent Adverse Events (TEAE)
Time frame: Weeks 0-26

Results and safety

Results posted to the registry on 17 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 BID	138	113
IDeg OD+IAsp	136	117

Primary outcome: Change From Baseline in HbA1c (%)

Time frame: Week 0, week 26. Least squares mean (Standard Error). Unit: percentage change in HbA1c

Measure	IDegAsp BID n = 138	IDeg OD+IAsp n = 136
Value	-1.23 (0.13)	-1.42 (0.12)

Population analysed: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation "as randomised".

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events (AEs) were collected for a duration of 28 weeks ie. from the first trial-related activity after the subject had signed the informed consent until the end of the post-treatment follow-up period (visit 29).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IDegAsp BID	7 of 136 (5.1%)	46 of 136 (33.8%)	Not reported
IDeg OD+IAsp	13 of 135 (9.6%)	38 of 135 (28.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26592732Rodbard HW, Cariou B, Pieber TR, Endahl LA, Zacho J, Cooper JG. Treatment intensification with an insulin degludec (IDeg)/insulin aspart (IAsp) co-formulation twice daily compared with basal IDeg and prandial IAsp in type 2 diabetes: a randomized, controlled phase III trial. Diabetes Obes Metab. 2016 Mar;18(3):274-80. doi: 10.1111/dom.12609. Epub 2016 Jan 11.
Results publication: PubMed 29451706Haluzik M, Fulcher G, Pieber TR, Bardtrum L, Tutkunkardas D, Rodbard HW. The co-formulation of insulin degludec and insulin aspart lowers fasting plasma glucose and rates of confirmed and nocturnal hypoglycaemia, independent of baseline glycated haemoglobin levels, disease duration or body mass index: A pooled meta-analysis of phase III studies in patients with type 2 diabetes. Diabetes Obes Metab. 2018 Jul;20(7):1585-1592. doi: 10.1111/dom.13261. Epub 2018 Mar 25.
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

51 sites in 5 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, insulin degludec and insulin aspart in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 51 sites in 5 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 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, France, Austria, Norway, Algeria. 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 17 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?

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 NCT01713530, 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 2 Apr 2018.