Safety and Efficacy of THR-1442 Compared to Dapagliflozin as Add-on Therapy to Metformin in T2DM
- Sponsor
- Newsoara Biopharma Co., Ltd.
- Study ID
- NCT05159882
- Phase
- PHASE3
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- THR-1442 and Dapagliflozin placebo — DRUGTHR-1442 tablets 20mg and Dapagliflozin tablets placebo
- Dapagliflozin 10mg and THR1442 placebo — DRUGDapagliflozin tablets 10mg and THR-1442 tablets placebo
Study Details
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).
Key Dates
- Start date
- Apr 15, 2021
- Status verified
- Nov 2021
- Primary completion
- Sep 30, 2022
- Completion
- Sep 30, 2022
Study Design
- Enrollment
- 390 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: THR-1442 20mgEach subject will receive THR-1442 20 mg and Dapagliflozin placebo, once daily for the duration of the study.
- Active Comparator: Dapagliflozin10mgEach subject will receive Dapagliflozin 10 mg and THR-1442 placebo, once daily for the duration of the study.
Primary Outcome Measure
Change From Baseline in HbA1c at Week 24 [ Time Frame: Baseline to week 24 ]
Central Contacts
- Owen Zhang8621-52998027
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