drugset / Trial / NCT04465877
Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes
RandomizedParallel-groupSingle-blindTreatment
Summary
This study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of JTT-662 administered once daily for 28 days in subjects with Type 2 diabetes mellitus (T2DM) who are receiving metformin monotherapy
Timeline
- Start
- 2020-06-15
- Primary completion
- 2021-02-17
- Completion
- 2021-02-17
Outcome
Met primary endpoint
registry analysis (superiority test); JTT-662 10 mg vs Placebo; p = 0.016; Mean Difference (Final Values) -100.02 (95% CI -179.96 to -20.08); Mixed Models Analysis NCT04465877 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JTT-662 | Unknown | 5 mg | Oral |
| Subject | JTT-662 | Unknown | 10 mg | Oral |
| Subject | JTT-662 | Unknown | 20 mg | Oral |