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NCT03982381CompletedPhase 4

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

Source: ClinicalTrials.gov · Last updated 4 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
2067 (actual)
First submitted
27 May 2019
Start date
5 Sept 2019
Primary completion date
31 Jan 2026
Lead sponsor
Uppsala University
NCT number
NCT03982381
EU CT number
2024-516228-33-00
EudraCT number
2019-001046-17

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 2067
  • From 5 Sept 2019 to the primary completion date, 31 Jan 2026
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Known or suspected other form of diabetes than type 2
  • 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)
  • 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

Lab values

  • HbA1c \>70 mmol/mol for patients on monotherapy, \>80 in drug naïve
  • Renal impairment (eGFR \<60 ml/min/1,73m2)

Other

  • Medical need to start or intensify any specific GLD treatment, e.g. insulin due to marked hyperglycemia
  • Contraindication to either metformin or dapagliflozin, or any unacceptable risk with either treatment as assessed by the investigator
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Region Dalarna
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FalunSwedenCompleted
Region Gaevleborg
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GavleSwedenCompleted
Stift Carlanderska Sjukhuset
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GoteborgSwedenCompleted
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
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GoteborgSwedenCompleted
Region Joenkoepings Laen
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JonkopingSwedenCompleted
Region Vaermland
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KarlstadSwedenCompleted
Region Oestergoetland
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LinkopingSwedenCompleted
Region Norrbotten
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LuleaSwedenCompleted
Region Skane Skanes Universitetssjukhus
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LundSwedenCompleted
Region Skane Skanes Universitetssjukhus
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MalmoSwedenCompleted
Region Soermland
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NykopingSwedenCompleted
Region Oerebro Laen
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OrebroSwedenCompleted
Region Stockholm – SLSO
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StockholmSwedenCompleted
Region Vaesterbotten
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UmeaSwedenCompleted
Region Uppsala
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UppsalaSwedenCompleted
Uppsala University Hospital
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UppsalaSwedenCompleted
Vaestra Goetalandsregionen
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VänersborgSwedenCompleted
Region Kronoberg
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VaxjoSwedenCompleted
Region Gotland
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VisbySwedenCompleted
Capio vardcentral Orust
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-SwedenCompleted

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.