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NCT01336023: DUAL™ I

Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes

Completed Phase 3 Results posted Last updated 19 February 2018
What this trial tests

Phase 3 trial testing insulin degludec/liraglutide in Diabetes in 1,663 participants. Completed in 22 November 2012.

Timeline
23 May 2011
Primary endpoint
24 May 2012
22 November 2012

Quick facts

Lead sponsorNovo Nordisk A/S
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment1,663
Start date23 May 2011
Primary completion24 May 2012
Estimated completion22 November 2012
Sites302 locations across Italy, Finland, Malaysia, Taiwan, Ireland, Russia, Mexico, Thailand

Drugs / interventions tested

Conditions studied

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26. Primary · Week 0, week 26

Values of mean change in HbA1c.

GroupValue95% CI
IDeg-1.44± 1.03
IDegLira-1.91± 1.07
Liraglutide-1.28± 1.13
Mean Change From Baseline in Body Weight at Week 26 Secondary · Week 0, Week 26

Values of mean change in body weight.

GroupValue95% CI
IDeg1.6± 4.0
IDegLira-0.5± 3.5
Liraglutide-3.0± 3.5
Number of Hypoglycaemic Episodes Secondary · Weeks 0-26

Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.

GroupValue95% CI
IDeg256.7
IDegLira180.2
Liraglutide22.0
Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test Secondary · Week 0, Week 26

Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.

GroupValue95% CI
IDeg-0.17± 1.98
IDegLira-0.87± 1.65
Liraglutide-0.78± 1.62
Mean Actual Daily Insulin Dose Secondary · Week 26

Mean of the actual doses recorded at visit 28 (Week 26).

GroupValue95% CI
IDeg53± 28
IDegLira38± 13

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events (AEs) were collected from first day of exposure to randomised treatment of 52 weeks (26 week main period + 26 week extension period) + 7 days follow-up after the last day on randomised treatment.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

IDeg
Serious: 22/412 (5%)
Deaths:
IDegLira
Serious: 38/825 (5%)
Deaths:
Liraglutide
Serious: 24/412 (6%)
Deaths:

Serious adverse events (83 terms)

ReactionSystemIDegIDegLiraLiraglutide
OsteoarthritisMusculoskeletal and connective tissue disorders
Acute myocardial infarctionCardiac disorders
Angina pectorisCardiac disorders
Angina unstableCardiac disorders
Umbilical herniaGastrointestinal disorders
Biliary colicHepatobiliary disorders
CholelithiasisHepatobiliary disorders
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders
Coronary artery bypassSurgical and medical procedures
Acute coronary syndromeCardiac disorders
Atrial fibrillationCardiac disorders
Coronary artery dilatationCardiac disorders
Coronary artery diseaseCardiac disorders
Myocardial ischaemiaCardiac disorders
GoitreEndocrine disorders
Angle closure glaucomaEye disorders
CataractEye disorders
Necrotising retinitisEye disorders
Vitreous haemorrhageEye disorders
Colitis ischaemicGastrointestinal disorders
GastritisGastrointestinal disorders
Gastrointestinal haemorrhageGastrointestinal disorders
Gastrooesophageal reflux diseaseGastrointestinal disorders
Pancreatitis acuteGastrointestinal disorders
Small intestinal obstructionGastrointestinal disorders
Other adverse events (13 terms — click to expand)

ReactionSystemIDegIDegLiraLiraglutide
NasopharyngitisInfections and infestations
HeadacheNervous system disorders
NauseaGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
Upper respiratory tract infectionInfections and infestations
Lipase increasedInvestigations
Back painMusculoskeletal and connective tissue disorders
VomitingGastrointestinal disorders
Decreased appetiteMetabolism and nutrition disorders
ArthralgiaMusculoskeletal and connective tissue disorders
DyspepsiaGastrointestinal disorders
ConstipationGastrointestinal disorders
DizzinessNervous system disorders

Most-reported serious reactions: Osteoarthritis, Acute myocardial infarction, Angina pectoris, Angina unstable, Umbilical hernia, Biliary colic, Cholelithiasis, Chronic obstructive pulmonary disease.

Data from ClinicalTrials.gov NCT01336023 adverse events section.

Sponsor's own description

This trial is conducted globally. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin degludec (IDeg) and liraglutide (Lira) in subjects with type 2 diabetes. Subjects are to continue their pre-trial treatment with metformin or metformin + pioglitazone throughout the entire trial.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Efficacy and safety of a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with its components given alone: results of a phase 3, open-label, randomised, 26-week, treat-to-target trial in insulin-naive patients with type 2 diabetes.
    Gough SC, Bode B, Woo V, Rodbard HW, et al · · 2014 · cited 255× · PMID 25190523 · DOI 10.1016/s2213-8587(14)70174-3
  2. Glucagon-like peptide analogues for type 2 diabetes mellitus.
    Shyangdan DS, Royle P, Clar C, Sharma P, et al · · 2011 · cited 123× · PMID 21975753 · DOI 10.1002/14651858.cd006423.pub2
  3. Combination therapy with GLP-1 receptor agonists and basal insulin: a systematic review of the literature.
    Balena R, Hensley IE, Miller S, Barnett AH. · · 2013 · cited 109× · PMID 23061470 · DOI 10.1111/dom.12025
  4. One-year efficacy and safety of a fixed combination of insulin degludec and liraglutide in patients with type 2 diabetes: results of a 26-week extension to a 26-week main trial.
    Gough SC, Bode BW, Woo VC, Rodbard HW, et al · · 2015 · cited 95× · PMID 25980900 · DOI 10.1111/dom.12498
  5. Use of GLP-1 Receptor Agonists and Occurrence of Thyroid Disorders: a Meta-Analysis of Randomized Controlled Trials.
    Hu W, Song R, Cheng R, Liu C, et al · · 2022 · cited 72× · PMID 35898463 · DOI 10.3389/fendo.2022.927859
  6. Glucagon-like peptide-1 receptor agonists: a systematic review of comparative effectiveness research.
    Levin PA, Nguyen H, Wittbrodt ET, Kim SC. · · 2017 · cited 72× · PMID 28435305 · DOI 10.2147/dmso.s130834
  7. Benefits of combination of insulin degludec and liraglutide are independent of baseline glycated haemoglobin level and duration of type 2 diabetes.
    Rodbard HW, Buse JB, Woo V, Vilsbøll T, et al · · 2016 · cited 27× · PMID 26343931 · DOI 10.1111/dom.12574
  8. IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy.
    Freemantle N, Mamdani M, Vilsbøll T, Kongsø JH, et al · · 2015 · cited 19× · PMID 26582052 · DOI 10.1007/s13300-015-0142-y

Verify or expand the search:

Other trials of insulin degludec/liraglutide

Trials testing the same drug.

Other recruiting trials for Diabetes

Currently open trials in the same condition.

Other Novo Nordisk A/S trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01336023.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing