At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IIa, Randomised, Parallel, Double-Blind,Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Diet and Exercise
In Brief
A Phase 2 clinical trial evaluating MEDI0382 100 μg, MEDI0382 200 μg, and 4 other interventions for Type 2 Diabetes. Completed, enrolled 61 participants across 5 sites.
Detailed Summary
This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects. The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.
Study Details
Timeline
Interventions
Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose
Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose
Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose
1.0 mL liquid formulation per Vial
Solution for injection, 1.0 mL per vial, 50 ug
Solution for injection in 1.0 mL pre-filled syringe.