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COMPLETEDPHASE4

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

NCT03982381•Uppsala University

View on ClinicalTrials.gov

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.

Detailed Description

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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (1)

Uppsala University Hospital

Uppsala, Sweden

Key Dates

Start Date

September 5, 2019

Primary Completion Date

January 31, 2026

Completion Date

January 31, 2026

Last Updated

March 4, 2026

Enrollment

2,067

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Metformin

DRUG

Dapagliflozin 10 MG

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

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