Safety and efficacy of fixed-dose combination of dapagliflozin and saxagliptin in patients with type 2 diabetes mellitus - a phase 4 study in India.

ABSTRACT:

Objective

To determine the post-marketing safety profile of a once-daily fixed-dose combination (FDC) of dapagliflozin (10 mg) and saxagliptin (5 mg) given orally for 24 weeks or until discontinuation, in Indian patients with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin.

Design

Prospective, single-arm, multicenter study.

Setting

Adult patients with T2DM enrolled from April 2021 to March 2023 across 9 study sites in India.

Outcome measures

The primary objective was to determine the adverse event (AE) profile of the FDC. Additionally, we assessed changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), systolic blood pressure, and body weight at 24 weeks, compared to baseline.

Results

Of the 196 patients (median age [ran

SUBMITTER: Wangnoo SK 

PROVIDER: S-EPMC11911173 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature