Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes
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.
Timeline
- Start
- 2018-08-10
- Primary completion
- 2019-01-17
- Completion
- 2019-01-17
Outcome
Mixed primary results
registry analysis (other test); Placebo vs MEDI0382 100 mcg; p <0.0001; Least squares (LS) mean difference -42.11 (95% CI -50.47 to -33.75); ANCOVA NCT03645421 ↗
registry analysis (other test); Placebo vs MEDI0382 100 mcg; p = 0.1476; LS mean difference -1.30 (95% CI -3.08 to 0.47); ANCOVA NCT03645421 ↗
registry analysis (other test); Placebo vs MEDI0382 200 mcg; p = 0.0080; LS mean difference -2.53 (95% CI -4.37 to -0.69); ANCOVA NCT03645421 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cotadutide | Peptide | 100 ug | Subcutaneous |
| Subject | Cotadutide | Peptide | 200 ug | Subcutaneous |
| Subject | Cotadutide | Peptide | 300 ug | Subcutaneous |