Safety And Efficacy Of Empagliflozin In Pakistani Muslim Population With Type Ii Diabetes Mellitus

Sponsor
Getz Pharma
Study ID
NCT04665284
Phase
PHASE4
Status
Completed

Conditions

  • Type II Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Empagliflozin — DRUG
    Group A: Empagliflozin 10/25 mg once daily with or without antidiabetic drugs
  • Usual care group — DRUG
    Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care

Study Details

To compare the safety and efficacy of empagliflozin versus other treatments in Pakistani Muslim population with type II diabetes mellitus.

Key Dates

Start date
Jun 1, 2019
Status verified
Dec 2020
Primary completion
Sep 15, 2020
Completion
Sep 28, 2020

Study Design

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

Arms

  • Experimental: Empagliflozin
  • Active Comparator: Usual Care Group

Primary Outcome Measure

Number of participants reported adverse events [ Time Frame: 24 weeks ]

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