drugset / Trial / NCT04465877

Study to Evaluate Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of JTT-662 in Subjects With Type 2 Diabetes

NCT04465877 ↗

Phase 1 Completed 37 enrolled Akros Pharma Inc.
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

EvaluationDrugModalityDoseRoute
Subject JTT-662 Unknown 5 mg Oral
Subject JTT-662 Unknown 10 mg Oral
Subject JTT-662 Unknown 20 mg Oral