Using empagliflozin to improve diabetes management in cystic fibrosis patients
Empagliflozin in CFRD: Efficacy and Safety of SGLT2 Inhibitor Therapy in Overweight and Obese Subjects With Cystic Fibrosis-related Diabetes: a Pilot Study
This study is testing if adding empagliflozin to insulin can help overweight or obese adults with cystic fibrosis-related diabetes manage their blood sugar better.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06149793 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety, tolerability, and feasibility of empagliflozin, an SGLT2 inhibitor, as an add-on therapy to insulin for overweight or obese adults with cystic fibrosis-related diabetes (CFRD). The study will be a placebo-controlled, randomized, double-blind, crossover design with a 4-week washout period. Participants will be monitored for glycemic control improvements and any adverse effects associated with the medication. The findings will help inform a larger randomized controlled trial in the future.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with cystic fibrosis-related diabetes who are overweight or obese and currently on insulin treatment.
Not a fit: Patients with type 1 diabetes, recent acute pulmonary exacerbations, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance glycemic control in patients with cystic fibrosis-related diabetes, potentially improving their overall health and quality of life.
How similar studies have performed: While the use of SGLT2 inhibitors in diabetes management is established, this specific application in cystic fibrosis-related diabetes is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Study coordinator: Amir Moheet, MBBS
- Email: mohee002@umn.edu
- Phone: 612-625-2153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.