drugset / Trial / NCT03444584

Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes

NCT03444584 ↗

Phase 2 Completed 49 enrolled MedImmune LLC
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Phase 2 study Comparing the effects on glucose control of MEDI0382 in combination with Dapagliflozin and Metformin compared to placebo in combination with Dapagliflozin and Metformin in overweight/obese participants with Type 2 Diabetes Mellitus (T2DM).

Timeline

Start
2018-05-08
Primary completion
2018-12-06
Completion
2018-12-06

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo vs MEDI0382; p <0.0001; LS mean difference -143.09 (95% CI -198.20 to -87.98); ANCOVA NCT03444584 ↗

registry analysis (superiority test); Placebo vs MEDI0382; p <0.0001; LS mean difference -22.17 (95% CI -30.24 to -14.10); ANCOVA NCT03444584 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Cotadutide Peptide 300 ug Subcutaneous
Background Dapagliflozin Small molecule 10 mg Oral
Background Metformin Small molecule — Oral