A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms

Summary

This trial is conducted in Europe, North America and the United States of America. The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.

Timeline

Start

2014-11-21

Primary completion

2015-12-23

Completion

2015-12-23

Outcome

Met primary endpoint

paper non-inferiority was confirmed (estimated treatment difference: 0.12% [-0.04; 0.28]95%CI , 1.30 mmol/mol [-0.41; 3.01]95%CI ). PMID 28124817 ↗

release “The first phase 3a trial for IDegLira, a fixed ratio combination of insulin degludec and liraglutide, demonstrates superior glucose control in the IDegLira-treated patients” novonordisk.com ↗

Publications

• Results Safety and Efficacy of Insulin Degludec/Liraglutide(IDegLira) Titrated Once Weekly (1 Wk) vs. Twice Weekly (2 Wk) in Patients (pts) with T2D Uncontrolled on Oral Antidiabetic Drugs: DUAL VI Study; Stewart B. Harris et al. American Diabetes Association - 76th Annual Scientific Sessions; 10 June 2016
• Results Harris SB, Kocsis G, Prager R, Ridge T, Chandarana K, Halladin N, Jabbour S. Safety and efficacy of IDegLira titrated once weekly versus twice weekly in patients with type 2 diabetes uncontrolled on oral antidiabetic drugs: DUAL VI randomized clinical trial. Diabetes Obes Metab. 2017 Jun;19(6):858-865. doi: 10.1111/dom.12892. Epub 2017 Mar 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin degludec/liraglutide	Unknown	—	Subcutaneous

Indications