NCT03317028

CS02 vs Placebo With Metformin in Type 2 Diabetes Mellitus (T2DM)

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of CS02 Tablet in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Center Laboratories, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to compare the efficacy and safety of 3 doses CS02 Tablet in combination with a stable dose of metformin monotherapy against CS02 PTM (placebo) Tablet in combination with a stable dose of metformin monotherapy over a 12 weeks treatment period in subjects with type 2 diabetes mellitus with inadequate glycemic control on metformin alone.

Conditions

• T2DM With Inadequate Glycemic Control

Interventions

Type	Name	Description
DRUG	CS02 tablet and placebo tablet	Subjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment.

Timeline

• Start date: 2017-10-10
• Primary completion: 2020-04-21
• Completion: 2020-04-21
• First posted: 2017-10-23
• Last updated: 2020-06-09

Locations

13 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study