NCT04465877

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

Single-blind, Randomized, Placebo-controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JTT-662 Administered for 28 Days in Subjects With Type 2 Diabetes Mellitus on Metformin Monotherapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Akros Pharma Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	JTT-662	Active drug tablets containing JTT-662
DRUG	Placebo	Placebo tablets matching in appearance to the active drug tablets

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-02-17
• Completion: 2021-02-17
• First posted: 2020-07-10
• Last updated: 2023-01-27
• Results posted: 2023-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study