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 4
  • Study Type

    Interventional
  • Status

    Recruiting
  • Study Participants

    4300
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.
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)
Study Started
Sep 05
2019
Primary Completion
Dec 31
2024
Anticipated
Study Completion
Sep 20
2025
Anticipated
Last Update
Apr 28
2021

Drug Metformin

Active comparator

Drug Dapagliflozin 10 MG

Experimental treatment

Metformin Active Comparator

Metformin 1000-3000 mg per day according to clinical guidelines. Split into 2-3 doses per day.

Dapagliflozin Experimental

Dapagliflozin 10 mg once daily

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.
No Results Posted