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

NCT01336023 · Completed

Last updated 2026-05-28

This clinical trial compares the effects of combining two diabetes medications, liraglutide and insulin degludec, against each medication alone in adults with type 2 diabetes.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 1,663 people

Who can join Ages 18+ · all sexes

Timeline Started 2011-05 · est. completion 2012-11

Where 302 sites · Australia, Canada, Finland, Germany, Hungary, India, Ireland, Italy, Malaysia, Mexico, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT01336023 ↗

Description as written by the study sponsor.

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.

Treatments tested

insulin degludec/liraglutide Drug

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 degludec Drug

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.
liraglutide Drug

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.

Main thing measured	Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2
GLP-1 drugs	liraglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT01336023 ↗