NCT03986073

Study of TQ-F3083 Capsules in Subjects With Type 2 Diabetes Mellitus

A Phase IIA , Multi-center, Randomized, Double-blind, Placebo and Positive Drug Parallel Control Study of TQ-F3083 Capsules With Different Doses in Subjects With Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

TQ-F3083 capsule is a new type inhibitor of DPP-IV, which is currently a very effective target for the treatment of type 2 diabetes mellitus at clinical. In addition, it can promote insulin secretion with low potential toxicity, and half-life is shorter than Linagliptin.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	TQ-F3083 capsule 10 mg	Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.
DRUG	TQ-F3083 capsule 20 mg	Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.
DRUG	TQ-F3083 blank analog capsule	Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.
DRUG	TQ-F3083 blank analog capsule	Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.
DRUG	Linagliptin blank analog tablet	Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.
DRUG	Linagliptin tablet	Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks.

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-06-30
• Completion: 2020-09-30
• First posted: 2019-06-14
• Last updated: 2020-03-13

Locations

9 sites across 1 country: China