Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM
NCT06327815 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 633
Last updated 2025-10-31
Summary
Study D1690L00149 is a 24-week, multicentre, randomized, parallel, interventional, non-inferiority, open-label study designed to compare the FDC Regimen of Dapagliflozin/Metformin XR with the Dapagliflozin co-administered with Metformin XR in glycemic lowering control, satisfaction and adherence in Chinese patients with T2DM.
Conditions
- Type 2 Diabetes Mellitus (T2DM)
Interventions
- DRUG
-
Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets
10 mg Dapagliflozin/1000 mg Metformin HCl extended-release
- DRUG
-
Dapagliflozin tablets and Metformin HCl extended-release tablets
Dapagliflozin tablets: 10 mg Metformin HCl extended-release tablets: 1000 mg
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Guang Wang · Beijing Chao Yang Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-15
- Primary Completion
- 2025-06-30
- Completion
- 2025-06-30
Countries
- China
Study Locations
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