NCT05159882

Safety and Efficacy of THR-1442 Compared to Dapagliflozin as Add-on Therapy to Metformin in T2DM

A Multicenter, Randomized, Double-Blind, Parallel, Active-Controlled Phase III Study on Metformin Combined With THR-1442 or Dapagliflozin in T2DM

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 390 (estimated)
• Sponsor: Newsoara Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of THR-1442 compared to Dapagliflozin as an add-on therapy to metformin in lowering hemoglobin A1c (HbA1c) levels in subjects with type 2 diabetes mellitus (T2DM).

Detailed description

Approximately 390 subjects with inadequately controlled T2DM on metformin were to be recruited from China. Subjects were randomly assigned to receive THR-1442 tablet, 20 mg, or Dapagliflozin tavlet,10 mg, in a ratio of 1:1 once daily for 24 weeks. Subjects were to continue taking metformin for the duration of the study.

Conditions

• T2DM

Interventions

Type	Name	Description
DRUG	THR-1442 and Dapagliflozin placebo	THR-1442 tablets 20mg and Dapagliflozin tablets placebo
DRUG	Dapagliflozin 10mg and THR1442 placebo	Dapagliflozin tablets 10mg and THR-1442 tablets placebo

Timeline

• Start date: 2021-04-15
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2021-12-16
• Last updated: 2021-12-16

Locations

6 sites across 1 country: China