NCT06149793Active, not recruitingPhase 2/3
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
Empagliflozin in CFRD: Efficacy and Safety of SGLT2 Inhibitor Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
This will be a placebo-controlled, randomized, double blind, crossover study with a 4 week wash out period. Collect pilot data on the safety, tolerability, and feasibility of empagliflozin therapy in overweight/obese patients with CFRD to support a future larger randomized controlled trial.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 20 Nov 2023
- Start date
- 8 Jan 2024
- Primary completion date
- 3 Jun 2025
- Lead sponsor
- University of Minnesota
- Diseases
- Obesity, Cystic fibrosis
- NCT number
- NCT06149793
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 8
- From 8 Jan 2024 to the primary completion date, 3 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Positive GAD 65 antibody or low fasting C-peptide (below the normal reference range of the lab)
- prior solid organ transplant
Other illness
- type 1 diabetes
- A history of diabetic ketoacidosis
- history of recurrent genital or urinary tract infections
- Hypersensitivity to empagliflozin or any excipients of Jardiance
- History of eating disorder
Lab values
- 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)
Other
- pregnancy or lactation
- Non-English speakers and those unable to read in English • Diminished capacity to consent (study staff will utilize the MacCAT-CR for assessment)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.