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
- Diseases
- Type 2 diabetes
- 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
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Region Dalarna Coordinator of this site? Confirm its status | Falun | Sweden | Completed |
| Region Gaevleborg Coordinator of this site? Confirm its status | Gavle | Sweden | Completed |
| Stift Carlanderska Sjukhuset Coordinator of this site? Confirm its status | Goteborg | Sweden | Completed |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Completed |
| Region Joenkoepings Laen Coordinator of this site? Confirm its status | Jonkoping | Sweden | Completed |
| Region Vaermland Coordinator of this site? Confirm its status | Karlstad | Sweden | Completed |
| Region Oestergoetland Coordinator of this site? Confirm its status | Linkoping | Sweden | Completed |
| Region Norrbotten Coordinator of this site? Confirm its status | Lulea | Sweden | Completed |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Completed |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Malmo | Sweden | Completed |
| Region Soermland Coordinator of this site? Confirm its status | Nykoping | Sweden | Completed |
| Region Oerebro Laen Coordinator of this site? Confirm its status | Orebro | Sweden | Completed |
| Region Stockholm – SLSO Coordinator of this site? Confirm its status | Stockholm | Sweden | Completed |
| Region Vaesterbotten Coordinator of this site? Confirm its status | Umea | Sweden | Completed |
| Region Uppsala Coordinator of this site? Confirm its status | Uppsala | Sweden | Completed |
| Uppsala University Hospital Coordinator of this site? Confirm its status | Uppsala | Sweden | Completed |
| Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Vänersborg | Sweden | Completed |
| Region Kronoberg Coordinator of this site? Confirm its status | Vaxjo | Sweden | Completed |
| Region Gotland Coordinator of this site? Confirm its status | Visby | Sweden | Completed |
| Capio vardcentral Orust Coordinator of this site? Confirm its status | - | Sweden | Completed |
Related publications
- SGLT2 inhibitor or metformin as standard treatment in early-stage type 2 diabetes? Baseline data in SMARTEST, a novel, decentralised, register-based randomised trial on prevention of diabetic complications.Diabetes Obes Metab · 2026 · PMID 41311237
- Metformin for preventing the progression of chronic kidney disease.Cochrane Database Syst Rev · 2024 · PMID 38837240
- A registry-based randomised trial comparing an SGLT2 inhibitor and metformin as standard treatment of early stage type 2 diabetes (SMARTEST): Rationale, design and protocol.J Diabetes Complications · 2021 · PMID 34389234
- Metformin monotherapy for adults with type 2 diabetes mellitus.Cochrane Database Syst Rev · 2020 · PMID 32501595
This page is information, not medical advice. Discuss any trial with your doctor.