The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

Phase 3 Completed 346 enrolled Novo Nordisk A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.

Timeline

Start: 2012-10-01
Primary completion: 2013-12-31
Completion: 2013-12-31

Outcome

Met primary endpoint

paper IDeg add-on to liraglutide arm (-1.04%) than in the placebo add-on to liraglutide arm (-0.16%; p < 0.0001). PMID 26990378 ↗

Publications

Results Aroda VR, Bailey TS, Cariou B, Kumar S, Leiter LA, Raskin P, Zacho J, Andersen TH, Philis-Tsimikas A. Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study). Diabetes Obes Metab. 2016 Jul;18(7):663-70. doi: 10.1111/dom.12661. Epub 2016 May 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin degludec	Protein / enzyme biologic	—	Subcutaneous
Background	Liraglutide	Peptide	1.8 mg	Subcutaneous