Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes

Sponsor
Tan Tock Seng Hospital
Study ID
NCT05440591
Phase
PHASE4
Status
Unknown

Conditions

  • Diabetes

Eligibility Criteria

Sex
ALL
Age
30 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

Trial Design: This is a 12 week randomised controlled open label trial comparing the impact of Dapagliflozin, Metformin and combination therapy on vascular function in newly diagnosed T2DM patients.

Key Dates

Start date
Apr 1, 2019
Status verified
Jun 2022
Primary completion
May 10, 2023
Completion
May 10, 2023

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin
    Metformin XR 500 mg tablets - up-to twice daily orally.
  • Experimental: Dapagliflozin
    Dapagliflozin 10 mg tablets - once daily
  • Experimental: MetforminXR 500/Dapagliflozin 5mg
    MetforminXR 500/Dapagliflozin 5mg , tablets- once daily

Primary Outcome Measure

Endothelial Function measured as reactive hyperaemia index (RHI-EndoPAT) [ Time Frame: 3 months after initiation ]

Central Contacts

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