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

Phase 2 Completed 201 enrolled Center Laboratories, Inc.

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2017-10-10
Primary completion: 2020-04-21
Completion: 2020-04-21

Outcome

Met primary endpoint

paper At week 12, significant reductions in HbA1c were observed for R-Vera 300 mg/day (-0.36, P = 0.0373) and 450 mg/day (-0.45, P = 0.0098) compared with placebo. PMID 35917580 ↗

Publications

Wang CY, Huang KC, Lu CW, Chu CH, Huang CN, Chen HS, Lee IT, Chen JF, Chen CC, Chen CS, Hsieh CH, Tien KJ, Chien HY, Huang YY, Hsu JP, Shane GT, Chang AC, Wu YC, Sheu WH. A Randomized Controlled Trial of R-Form Verapamil Added to Ongoing Metformin Therapy in Patients with Type 2 Diabetes. J Clin Endocrinol Metab. 2022 Sep 28;107(10):e4063-e4071. doi: 10.1210/clinem/dgac436.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	R-form verapamil	Unknown	150 mg	—
Subject	R-form verapamil	Unknown	300 mg	—
Subject	R-form verapamil	Unknown	450 mg	—
Background	Metformin	Small molecule	—	—

Indications

No indication recorded.