Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

Completed 30 enrolled Indiana University Novo Nordisk A/S · collab

RandomizedParallel-groupOpen-labelOther

Summary

27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).

Timeline

Start: 2012-01
Primary completion: 2017-09-08
Completion: 2017-09-08

Outcome

Missed primary endpoint

registry analysis (superiority test); Iiraglutide vs Insulin Detemir vs Liraglutide Plus Insulin Detemir; p = 0.65; Kruskal-Wallis NCT01232946 ↗

registry analysis (superiority test); Iiraglutide vs Insulin Detemir vs Liraglutide Plus Insulin Detemir; p = 0.065; Kruskal-Wallis NCT01232946 ↗

registry analysis (superiority test); Iiraglutide vs Insulin Detemir vs Liraglutide Plus Insulin Detemir; p = 0.80; Kruskal-Wallis NCT01232946 ↗

Publications

Mather KJ, Considine RV, Hamilton L, Patel NA, Mathias C, Territo W, Goodwill AG, Tune JD, Green MA, Hutchins GD. Combination GLP-1 and Insulin Treatment Fails to Alter Myocardial Fuel Selection vs. Insulin Alone in Type 2 Diabetes. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3456-3465. doi: 10.1210/jc.2018-00712.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Liraglutide	Peptide	1.8 mg	Subcutaneous
Subject	insulin detemir	Protein / enzyme biologic	5 iu	Subcutaneous