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

• Status: Recruiting
• Trial end date: 2025-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Uppsala University
• Collaborators: Swedish Healthcare Regions; Swedish National Board of Health and Welfare; The Swedish National Diabetes Register; Uppsala University Hospital
• Treatments: 2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol; Dapagliflozin; Metformin

Criteria

Inclusion Criteria:

• Men and women ≥18 years old

• T2D (according to World Health Organization (WHO) criteria) of less than 4 years duration

• BMI 18.5-45 kg/m2

• Drug naïve or oral monotherapy with glucose-lowering drug.

• Accepting NDR participation and other register data collection.

Exclusion Criteria:

• Known or suspected other form of diabetes than type 2

• Ongoing or more than >4 weeks in total of any previous treatment with: insulin, GLP-1 receptor agonists, SGLT2 inhibitors or combination of any diabetes medications

• Medical need to start or intensify any specific GLD treatment, e.g. insulin due to marked hyperglycemia

• HbA1c >70 mmol/mol for patients on monotherapy, >80 in drug naïve

• Contraindication to either metformin or dapagliflozin, or any unacceptable risk with either treatment as assessed by the investigator

• History or signs of established cardiovascular disease: diagnosis of myocardial infarction, angina pectoris, heart failure, stroke, lower extremity arterial disease, any limb amputation (except due to trauma or malignancy)

• Any serious illness or other condition with short life expectancy (<4 yr)

• Renal impairment (eGFR <60 ml/min/1,73m2)

• Any condition, as judged by the investigator, that suggests that the patient will be non-compliant or otherwise unsuitable to study medication or study participation

• Pregnancy or breastfeeding, women of childbearing potential (WOCBP; including perimenopausal women who have had a menstrual period within 1 year) without adequate anticonception during any part of the study period

• Involvement in the planning and/or conduct of the study

• Ongoing participation in another clinical trial.