Title
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
Phase
Phase 4Lead Sponsor
Uppsala UniversityStudy Type
InterventionalStatus
Active, not recruitingIndication/Condition
Type 2 DiabetesIntervention/Treatment
Metformin Dapagliflozin 10 MGStudy Participants
2067A 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.
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)
Active comparator
Experimental treatment
Metformin 1000-3000 mg per day according to clinical guidelines. Split into 2-3 doses per day.
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.