To Assess Safety of Fixed Dose Combination of Dapagliflozin and Saxagliptin in Type 2 Diabetes Mellitus Patients

Sponsor
AstraZeneca
Study ID
NCT04445714
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • dapagliflozin and saxagliptin — DRUG
    Combination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally

Study Details

A prospective, multicenter, phase -IV study to assess the safety of fixed dose combination of dapagliflozin and saxagliptin in Indian Type 2 Diabetes Mellitus (T2D) patients.

Key Dates

Start date
Apr 7, 2021
Status verified
Sep 2024
Primary completion
Mar 14, 2023
Completion
Mar 14, 2023

Study Design

Enrollment
196 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: dapagliflozin and saxagliptin
    Singe arm once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally

Primary Outcome Measure

Adverse Events (AEs) Including Serious Adverse Events (SAEs), AEs Leading to Discontinuation (DAE), and Adverse Events of Special Interest [ Time Frame: Baseline to End of Study (Week 26) ]

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