CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,663 enrolled
Drug / intervention
insulin degludec/liraglutide +2 moredrug
Likely dose
liraglutide 0.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01336023
NCT01336023Phase 3Completed
CompareCT.gov

A 26 Week Randomised, Parallel Three-arm, Open-label, Multi-centre, Multinational Treat-to-target Trial Comparing Fixed Ratio Combination of Insulin Degludec and Liraglutide Versus Insulin Degludec or Liraglutide Alone, in Subjects With Type 2 Diabetes Treated With 1-2 Oral Anti-diabetic Drugs (OADs)With a 26 Week Extension

Novo Nordisk A/S·interventional·Posted Apr 15, 2011·Updated Feb 19, 2018

In Brief

A Phase 3 clinical trial evaluating insulin degludec/liraglutide, insulin degludec, and 1 other intervention for Diabetes and Diabetes Mellitus, Type 2. Completed, enrolled 1,663 participants across 302 sites in 20 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes, Diabetes Mellitus, Type 2
CountriesAustralia, Canada, Finland, Germany, Hungary, India, Ireland, Italy, Malaysia, Mexico, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 15, 2011
Enrollment StartMay 23, 2011
Primary CompletionMay 24, 2012
Study CompletionNov 22, 2012
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 15.2 years ago

Interventions

insulin degludec/liraglutidedrug

Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily.

insulin degludecdrug

Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.

liraglutidedrug

Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.