NCT05440591

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

Effects of Dapagliflozin and Metformin on Vascular Function in Newly-Diagnosed Treatment-Naive Type 2 Diabetes- A Randomised Controlled Trial (DMVascular Study)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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. Trial Participants: Approximately 150 newly diagnosed T2DM patients with randomization 1:1:1 to Metformin XR 500mg twice daily, Dapagliflozin 10 mg daily or Metformin XR 500/Dapagliflozin 5 mg daily Primary Aim : To evaluate the influence of intervention on vascular function. Secondary Aims: 1. To evaluate the influence on other parameters of vascular function and beds. 2. To evaluate the haemodynamics involving blood pressure regulation. 3. To evaluate the effects of SGLT2i versus Metformin on endothelial interactions (vascular permeability) and leukocyte-endothelial interactions (leukocyte rolling, adherence), endothelial regenerative capacity and other endothelial related pathways.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	Dapagliflozin	Dapagliflozin 10mg tablets
DRUG	MetFORMIN 500 Mg Oral Tablet	Metformin 500 mg tablets twice daily
DRUG	Dapagliflozin / metFORMIN Pill	Combination pill

Timeline

• Start date: 2019-04-01
• Primary completion: 2023-05-10
• Completion: 2023-05-10
• First posted: 2022-07-01
• Last updated: 2022-07-01

Locations

1 site across 1 country: Singapore