A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus.
Summary
This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese subjects with type 2 diabetes mellitus.
Timeline
- Start
- 2015-11-18
- Primary completion
- 2017-12-15
- Completion
- 2017-12-22
Outcome
Met primary endpoint
paper confirming non-inferiority of IDegLira to degludec and superiority of IDegLira to liraglutide (P < .0001 for both [primary endpoint]). PMID 31407845 ↗
registry analysis (non-inferiority test); Insulin Degludec/Liraglutide vs Insulin Degludec; p <0.0001; Treatment contrast -0.63 (95% CI -0.75 to -0.52); ANCOVA; NCT02607306 ↗
registry analysis (superiority test); Insulin Degludec/Liraglutide vs Liraglutide; p <0.0001; Treatment contrast -0.48 (95% CI -0.60 to -0.37); ANCOVA; NCT02607306 ↗
Publications
- Results Kaku K, Araki E, Tanizawa Y, Ross Agner B, Nishida T, Ranthe M, Inagaki N. Superior efficacy with a fixed-ratio combination of insulin degludec and liraglutide (IDegLira) compared with insulin degludec and liraglutide in insulin-naive Japanese patients with type 2 diabetes in a phase 3, open-label, randomized trial. Diabetes Obes Metab. 2019 Dec;21(12):2674-2683. doi: 10.1111/dom.13856. Epub 2019 Aug 28.
- Results Komatsu M, Watada H, Kaneko S, Ross Agner BF, Nishida T, Kaku K. Efficacy and safety of the fixed-ratio combination of insulin degludec and liraglutide by baseline glycated hemoglobin, body mass index and age in Japanese individuals with type 2 diabetes: A subgroup analysis of two phase III trials. J Diabetes Investig. 2021 Sep;12(9):1610-1618. doi: 10.1111/jdi.13525. Epub 2021 Mar 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Liraglutide | Peptide | 1.8 mg | Subcutaneous |
| Subject | insulin degludec | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin degludec/liraglutide | Unknown | — | Subcutaneous |