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Two diabetes drugs better than one? new trial aims to find out

NCT ID NCT06613854

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether starting two diabetes drugs early—metformin plus either oral semaglutide or empagliflozin—controls blood sugar better than metformin alone in adults recently diagnosed with type 2 diabetes. About 90 participants will take the combination or just metformin for 26 weeks. Researchers will measure blood sugar levels, weight, and other health markers to see if the combo approach is safer and more effective.

What this could mean

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

Active substance
metformin with either oral semaglutide (Rybelsus) or empagliflozin (Jardiance)
What this could lead to
If successful, this could show that starting two diabetes drugs early helps control blood sugar better than metformin alone, potentially improving long-term outcomes.
What could go wrong
This is a small, early-phase trial with only 90 participants, so results may not apply to everyone. The study is short (26 weeks), so long-term benefits or risks are unknown.

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

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

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 to 70 years

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: * Diagnosed with type 2 diabetes for up to 2 years (prior to randomization); * Aged between 18 and 70 years, both sexes, of any race or ethnicity; * HbA1c ≤8.0% at randomization; * Baseline treatment with metformin at a steady daily dose of ≥1500 mg; * Signed informed consent to participate in the study. Exclusion Criteria: * Treatment at any time in the past with SGLT2i, GLP-1RA, or DPP-4 inhibitors; * Insulin treatment for longer than 2 weeks in the past; * Body Mass Index below 22 kg/m2 or BMI above 40 kg/m2; * Chronic kidney disease stages 3-5 (eGFR below 60 ml/min or the presence of albuminuria (urine albumin-to-creatinine ratio above 34 g/mmol); * Known cardiovascular disease (angina pectoris, history of myocardial infarction, ischemic heart disease, heart failure, known carotid atherosclerosis, objectively proven peripheral arterial disease, or other known atherosclerotic disease at other locations); * Moderate or severe liver disease (Child-Pugh stage B or C); * Personal history of pancreatitis; * Advanced heart failure (NYHA III-IV); * Retinopathy or maculopathy or their active treatment; * Pregnancy, expected pregnancy, or breastfeeding; * Presence of active malignancy or personal history of malignancy within 5 years of study enrollment; * Personal history of thyroid cancer; personal or family history of multiple endocrine neoplasia type 2 or family history of medullary thyroid carcinoma; * Chronic inflammatory bowel disease; * History of bariatric surgery or other gastrointestinal surgery that could affect drug or nutrient absorption; * Frequent or severe urinary tract infections; * Presence of a urinary catheter; * Troublesome and recurrent genital fungal infections; * Personal history of ketoacidosis; * Symptomatic hypotension or predisposition to hypovolemia; * History of organ transplantation; * Allergy to any component in the semaglutide or empagliflozin oral tablet; * Any medical or social circumstance that may limit participation in the study (e.g., inability to attend regular study visits); * Any other condition that, in the opinion of the principal and responsible investigators, may affect the safety or efficacy of the treatment.

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Conditions

The condition(s) this trial relates to.

Insulin Resistance type 2 diabetes mellitus

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Medical Centre Ljubljana, Diabetes Outpatient Clinic

    RECRUITING

    Ljubljana, 1000, Slovenia

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