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Diabetes Drug's cholesterol mystery: new study aims to unravel the why

NCT ID NCT03269058

Knowledge-focused Sponsor: Centre Hospitalier Universitaire Dijon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at why dapagliflozin, a diabetes drug, can raise 'bad' cholesterol levels. Researchers will track how the body makes and clears cholesterol in 28 adults with type 2 diabetes over 6 months. Half the participants will get dapagliflozin, the other half a placebo. The goal is to understand the problem so doctors can better manage cholesterol in these patients.

What this could mean

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

Active substance
Dapagliflozin
What this could lead to
If successful, this study could help doctors choose the right cholesterol-lowering drugs for people with type 2 diabetes who take dapagliflozin.
What could go wrong
This is a small, early-phase study with only 28 participants, so results may not apply to everyone. It aims to understand mechanisms, not prove a new treatment works.

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

28 people

The number who actually took part.

Started

Dec 2017

Finished

May 2021

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

30 to 65 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: * persons who have provided written consent * type 2 diabetes treated with OAD (metformin and/or sulfonylurea and/or glinides and/or acarbose and/or DPPIV inhibitors) * Stable treatment for 3 months * HbA1c between 7.5% and 10% * Age between 30 and 65 years * BMI between 25 and 35 kg/m² * Triglycerides \< 300 mg/dl * Half of the patients being treated with statins * eGFR \> 75 ml/min/1.73 m² at inclusion Exclusion Criteria: * persons without national health insurance cover * patients treated with Insulin or a GLP-1 agonist * Patients under guardianship * patients treated with lipid-lowering drugs (except statins for 50% of patients) * kidney failure * liver failure or abnormal liver function ASAT or ALAT \>3 x upper limit of normal * total bilirubin \>2mg/dl * intestinal disease * serological evidence of an active liver infection (surface antigen of hepatitis B, hepatitis C antibodies, hepatitis B IgM antibodies) * Pregnancy, breastfeeding * hypersensitivity to the active substance or to excipients * patients with volume depletion, for example due to an acute disease (gastro-intestinal disease) * patients treated with loop diuretics or thiazides

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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.

Oral antidiabetics Type 2 diabetes

Contacts and locations

Locations

  • CHU Dijon Bourgogne

    Dijon, 21079, France

More trials for these conditions

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