SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes

Sponsor
Uppsala University
Study ID
NCT03982381
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

A real-world, nationwide, register-based, randomised trial (RRCT) comparing SGLT2 inhibitors with metformin as standard treatment in early typ 2 diabetes. An open-label trial addressing efficacy with respect to clinically important macro- and microvascular events.

Key Dates

Start date
Sep 5, 2019
Status verified
Mar 2026
Primary completion
Jan 31, 2026
Completion
Jan 31, 2026

Study Design

Enrollment
2,067 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin
    Metformin 1000-3000 mg per day according to clinical guidelines. Split into 2-3 doses per day.
  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg once daily

Primary Outcome Measure

Time to first occurence of a confirmed composite endpoint of death, myocardial infarction, stroke, heart failure, diabetic nephropathy, retinopathy or foot ulcer. [ Time Frame: Time to first event during study period (for each patient 24-48 months, mean 36 months ) ]

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