Could a common diabetes drug help manage cystic Fibrosis-Related diabetes?
NCT ID NCT06149793
First seen Jun 25, 2026 · Last updated Sep 21, 2026 · Updated 2 times
Summary
This pilot study tests the safety and feasibility of empagliflozin (Jardiance) in 8 overweight or obese adults with cystic fibrosis-related diabetes (CFRD) who are already on insulin. Participants will receive either the drug or a placebo in a crossover design. The goal is to gather initial data to support a larger trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Empagliflozin (also known as Jardiance, a diabetes drug that helps lower blood sugar)
- What this could lead to
- If successful, this could point toward a new treatment option for managing diabetes in people with cystic fibrosis who are overweight or obese.
- What could go wrong
- This is a very small pilot study with only 8 participants, so results may not apply broadly. The drug may cause side effects or not work as hoped.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
8 people
The number who actually took part.
- Started
-
Jan 2024
- Expected to finish
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Dec 2026
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 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 Hide 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: * Adult subjects 18 years or older with CFRD and on insulin treatment * BMI \>25 kg/m2 * A participant who is capable of becoming pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study. These methods could include one of the following 1. Complete abstinence from sexual intercourse; 2. Tubal ligation; 3. Use combination of two forms of contraception during the study including, oral, injectable, or implanted hormonal contraceptives, intrauterine device or barrier method. Exclusion Criteria: * acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures * less than 12 weeks since start of a new CFTR corrector/modulator therapy * type 1 diabetes * Positive GAD 65 antibody or low fasting C-peptide (below the normal reference range of the lab) * A history of diabetic ketoacidosis * history of recurrent genital or urinary tract infections * pregnancy or lactation * prior solid organ transplant * Chronic liver disease (based on problem list in medical records or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times elevated above the upper limit of normal. * chronic kidney disease (eGFR \< 60mL/min/1.73 m2) * Hypersensitivity to empagliflozin or any excipients of Jardiance * History of eating disorder * Non-English speakers and those unable to read in English • Diminished capacity to consent (study staff will utilize the MacCAT-CR for assessment)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Minnesota
Minneapolis, Minnesota, 55455, United States
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Other studies related to the condition(s) this trial covers.
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