Effects of Dapagliflozin 10 mg on Insulin Resistance in Patients With Type 2 Diabetes Mellitus

Phase 4 Completed 55 enrolled AstraZeneca 43183 Mölndal · collab Antaros Medical · collab Bioventure Hub · collab Sweden · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This is an 8-week, single centre, randomized, parallel-group, double-blind, placebo-controlled Phase IV study to evaluate the effect of dapagliflozin on tissue specific insulin sensitivity in patients with Type 2 diabetes mellitus

Timeline

Start: 2015-03-23
Primary completion: 2016-04-28
Completion: 2016-04-28

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Dapagliflozin 10 MG vs Placebo; p = 0.9984; Mean Difference (Final Values) -0.0030 (95% CI -3.07 to 3.07); ANCOVA NCT02426541 ↗

Publications

Latva-Rasku A, Honka MJ, Kullberg J, Mononen N, Lehtimaki T, Saltevo J, Kirjavainen AK, Saunavaara V, Iozzo P, Johansson L, Oscarsson J, Hannukainen JC, Nuutila P. The SGLT2 Inhibitor Dapagliflozin Reduces Liver Fat but Does Not Affect Tissue Insulin Sensitivity: A Randomized, Double-Blind, Placebo-Controlled Study With 8-Week Treatment in Type 2 Diabetes Patients. Diabetes Care. 2019 May;42(5):931-937. doi: 10.2337/dc18-1569. Epub 2019 Mar 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dapagliflozin	Small molecule	10 mg	Oral