Study S002438

A Phase 3, Randomized, Double-blind, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HDM1002 Tablets Compared With Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin

ClinicalTrials.gov record

Registration

Registration: NCT07082114
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: RECRUITING
Enrollment: 800
Start: 2025-07-14
Primary completion: 2027-02-16
Lead sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Conditions: Type 2 Diabetes
Interventions: DRUG:HDM1002 100 mg; DRUG:HDM1002 200 mg; DRUG:HDM1002 400 mg; DRUG:Dapagliflozin (DAPA)
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Change From Baseline in HbA1c at Week 40 [Baseline, Week 40]

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