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

Study identifier:D1690L00149

ClinicalTrials.gov identifier:NCT06327815

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

Efficacy of FDC Regimen of Dapagliflozin/Metformin Compared to Co-administered Dual Therapy on Glycemic Control, Satisfaction and Adherence in Chinese Patients with T2DM: A 24-Week, Multicentre, Randomized, Parallel, Interventional, Non-inferiority, Open-label Study

Medical condition

Type 2 Diabetes Mellitus (T2DM)

Phase

Phase 4

Healthy volunteers

No

Study drug

Xigduo (Dapagliflozin and Metformin hydrochloride extended-release) tablets, Dapagliflozin tablets and Metformin HCl extended-release tablets

Sex

All

Estimated Enrollment

632

Study type

Interventional

Age

18 Years - 80 Years

Date

Study Start Date: 15 Mar 2024
Estimated Primary Completion Date: 30 Apr 2025
Estimated Study Completion Date: 30 Apr 2025

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria