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Which diabetes pill is better for Early-Stage patients? major trial compares dapagliflozin and metformin

NCT ID NCT03982381

Disease control Sponsor: Uppsala University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two common diabetes drugs—dapagliflozin and metformin—in over 2,000 people with early type 2 diabetes (diagnosed less than 4 years). The goal was to see which drug better prevents serious complications like death, heart attack, stroke, heart failure, kidney disease, eye problems, and foot ulcers. Participants took either dapagliflozin or metformin, and researchers tracked their health using national registries.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin (a drug that lowers blood sugar by helping the kidneys remove sugar through urine)
What this could lead to
If dapagliflozin works better than metformin, it could become a preferred first treatment for early type 2 diabetes to reduce the risk of serious complications like heart attack, stroke, and kidney disease.
What could go wrong
This is a completed Phase 4 trial, but it is open-label (patients and doctors know the treatment), which can bias results. Also, the benefit may be small or not apply to all patients with early diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

2,067 people

The number who actually took part.

Started

Sep 2019

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes

Contacts and locations

Locations

  • Uppsala University Hospital

    Uppsala, 75185, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.