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

  • STATUS
    Recruiting
  • End date
    Sep 20, 2025
  • participants needed
    4300
  • sponsor
    Uppsala University
Updated on 5 May 2021
metformin
sglt2 inhibitor
dapagliflozin
sglt2

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.

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 ) 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)

Details
Condition NIDDM, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Prevention, Diabetes Mellitus Types I and II, Diabetes (Pediatric), Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Metformin, Dapagliflozin 10 mg
Clinical Study IdentifierNCT03982381
SponsorUppsala University
Last Modified on5 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes Mellitus Types I and II or Diabetes Mellitus, Type 2 or Diabetes Mellitus or Diabetes Mellitus Type 2 or NIDDM or Diabetes Prevention or Diab...?
Do you have any of these conditions: diabetes type 2 or Diabetes (Pediatric) or type 2 diabetes mellitus or type 2 diabetes or Diabetes Mellitus Types I and II or Diabetes Prevention or D...?
Do you have any of these conditions: type 2 diabetes or Diabetes Mellitus or noninsulin-dependent diabetes mellitus or NIDDM or Diabetes Mellitus Types I and II or Diabetes (Pediatric) or...?
Do you have any of these conditions: Diabetes Mellitus Types I and II or noninsulin-dependent diabetes mellitus or type ii diabetes or Diabetes Mellitus Type 2 or type 2 diabetes mellitus...?
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 nave 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 naive
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
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