Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients With T2DM

Sponsor
AstraZeneca
Study ID
NCT06327815
Phase
PHASE4
Status
Completed

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 15, 2024
Status verified
Oct 2025
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
633 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Co-administered Dual Therapy
    Dapagliflozin tablets and Metformin HCl extended-release tablets
  • Experimental: FDC Regimen of Dapagliflozin/Metformin XR
    Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets

Primary Outcome Measure

Change in HbA1c from baseline [ Time Frame: 24 weeks ]

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