Values of mean change in HbA1c.
| Group | Value | 95% CI |
|---|---|---|
| IDeg | -1.44 | ± 1.03 |
| IDegLira | -1.91 | ± 1.07 |
| Liraglutide | -1.28 | ± 1.13 |
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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
Phase 3 trial testing insulin degludec/liraglutide in Diabetes in 1,663 participants. Completed in 22 November 2012.
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,663 |
| Start date | 23 May 2011 |
| Primary completion | 24 May 2012 |
| Estimated completion | 22 November 2012 |
| Sites | 302 locations across Italy, Finland, Malaysia, Taiwan, Ireland, Russia, Mexico, Thailand |
Novo Nordisk A/S — full company profile →
18 and older, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Values of mean change in HbA1c.
| Group | Value | 95% CI |
|---|---|---|
| IDeg | -1.44 | ± 1.03 |
| IDegLira | -1.91 | ± 1.07 |
| Liraglutide | -1.28 | ± 1.13 |
Values of mean change in body weight.
| Group | Value | 95% CI |
|---|---|---|
| IDeg | 1.6 | ± 4.0 |
| IDegLira | -0.5 | ± 3.5 |
| Liraglutide | -3.0 | ± 3.5 |
Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.
| Group | Value | 95% CI |
|---|---|---|
| IDeg | 256.7 | |
| IDegLira | 180.2 | |
| Liraglutide | 22.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| IDeg | -0.17 | ± 1.98 |
| IDegLira | -0.87 | ± 1.65 |
| Liraglutide | -0.78 | ± 1.62 |
Mean of the actual doses recorded at visit 28 (Week 26).
| Group | Value | 95% CI |
|---|---|---|
| IDeg | 53 | ± 28 |
| IDegLira | 38 | ± 13 |
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.
| Reaction | System | IDeg | IDegLira | Liraglutide |
|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — | — |
| Angina pectoris | Cardiac disorders | — | — | — |
| Angina unstable | Cardiac disorders | — | — | — |
| Umbilical hernia | Gastrointestinal disorders | — | — | — |
| Biliary colic | Hepatobiliary disorders | — | — | — |
| Cholelithiasis | Hepatobiliary disorders | — | — | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Coronary artery bypass | Surgical and medical procedures | — | — | — |
| Acute coronary syndrome | Cardiac disorders | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — |
| Coronary artery dilatation | Cardiac disorders | — | — | — |
| Coronary artery disease | Cardiac disorders | — | — | — |
| Myocardial ischaemia | Cardiac disorders | — | — | — |
| Goitre | Endocrine disorders | — | — | — |
| Angle closure glaucoma | Eye disorders | — | — | — |
| Cataract | Eye disorders | — | — | — |
| Necrotising retinitis | Eye disorders | — | — | — |
| Vitreous haemorrhage | Eye disorders | — | — | — |
| Colitis ischaemic | Gastrointestinal disorders | — | — | — |
| Gastritis | Gastrointestinal disorders | — | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — |
| Pancreatitis acute | Gastrointestinal disorders | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — |
| Reaction | System | IDeg | IDegLira | Liraglutide |
|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | — | — | — |
| Headache | Nervous system disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — |
| Lipase increased | Investigations | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Dizziness | Nervous 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.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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