A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus

Phase 3 Completed 420 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus.

Timeline

Start: 2016-05-23
Primary completion: 2017-09-26
Completion: 2017-10-23

Outcome

Met primary endpoint

registry analysis (superiority test); IDegLira vs IGlar; Treatment Contrast -0.36 (95% CI -0.50 to -0.21); ANCOVA NCT02773368 ↗

paper superiority of IDegLira (difference in HbA1c change -3.90 mmol/mol; 95% confidence interval [CI] -5.45; -2.35 (-0.36%-points; 95% CI -0.50, -0.21)). PMID 30761720 ↗

Publications

Results Philis-Tsimikas A, Billings LK, Busch R, Portillo CM, Sahay R, Halladin N, Eggert S, Begtrup K, Harris S. Superior efficacy of insulin degludec/liraglutide versus insulin glargine U100 as add-on to sodium-glucose co-transporter-2 inhibitor therapy: A randomized clinical trial in people with uncontrolled type 2 diabetes. Diabetes Obes Metab. 2019 Jun;21(6):1399-1408. doi: 10.1111/dom.13666. Epub 2019 Apr 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	insulin degludec/liraglutide	Unknown	—	Subcutaneous
Comparator	insulin glargine	Protein / enzyme biologic	—	Subcutaneous