NCT03982381

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

A Multicenter, Register-based, Randomized, Controlled Trial Comparing Dapagliflozin With Metformin Treatment in Early Stage Type 2 Diabetes Patients by Assessing Mortality and Macro- and Microvascular Complications

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,067 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

2067 type 2 diabetes (T2D) patients on monotherapy or drug naive. Randomization 1:1, metformin, dosing according to treatment guidelines or SGLT2 inhibitor, dapagliflozin 10 mg od. 844 events estimated for study completion (90% power to detect hazard ratio (HR) \<0.8 for dapagliflozin vs metformin ) Endpoint collection during study duration (about 4 years) from national health care registers: Patient, Prescribed drugs, Cause of death and Population registers; National diabetes register (NDR) Primary analysis according to insulin tolerance test (ITT)

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	Metformin	Active comparator
DRUG	Dapagliflozin 10 MG	Experimental treatment

Timeline

• Start date: 2019-09-05
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2019-06-11
• Last updated: 2026-03-04

Locations

1 site across 1 country: Sweden