SGLT2 Inhibitor or Metformin as Standard Treatment of Early Stage Type 2 Diabetes
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Type 2 Diabetes
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective randomized, open label, blinded endpoint design (PROBE). Multicenter study.Masking: Single (Outcomes Assessor)Masking Description: Treatment is blinded to outcome analysis team, until after database lockPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
4300 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 ) ...
4300 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)
Tracking Information
- NCT #
- NCT03982381
- Collaborators
- Uppsala University Hospital
- Swedish Healthcare Regions
- Swedish National Board of Health and Welfare
- The Swedish National Diabetes Register
- Investigators
- Principal Investigator: Jan Eriksson, MD Uppsala University
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