Using empagliflozin to improve diabetes management in cystic fibrosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Minnesota
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Amir Moheet, MBBS
• Email: mohee002@umn.edu
• Phone: 612-625-2153

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Continuous Glucose Monitoring to Screen for Diabetes in Cystic Fibrosis Patients

  This study is testing if using continuous glucose monitors can help better screen for diabetes in people with cystic fibrosis.

  Recruiting Medical College of Wisconsin · Milwaukee, Wisconsin · NCT06560463

• Investigating the impact of diet on diabetes risk in cystic fibrosis patients

  This study is testing if a low-added sugar, high-fat diet can lower diabetes risk in adults with cystic fibrosis compared to a standard high-sugar diet.

  Recruiting Emory University · Atlanta, Georgia · NCT05766774

• Effects of a Low Glycemic Load Diet on Diabetes and Body Composition in Adults with Cystic Fibrosis

  This study is testing if a low glycemic load diet can help adults with cystic fibrosis-related diabetes manage their blood sugar and improve their overall health.

  Recruiting at 2 sites Rhode Island Hospital · Boston, Massachusetts and 1 other locations · NCT05723445

• Metformin's effects on lung function in patients with cystic fibrosis-related diabetes

  This study is testing if metformin can help improve lung function in people with cystic fibrosis-related diabetes by giving them different doses of the medication over 14 weeks.

  Recruiting Phase 2 University of Kansas Medical Center · Kansas City, Kansas · NCT04530383

• Inhaled CFTR mRNA for cystic fibrosis in Chinese patients aged 12 and older

  This trial tests inhaled BMD003, a CFTR mRNA therapy, to see if it's safe and shows early signs of benefit in Chinese people 12 years and up with cystic fibrosis.

  Recruiting Early Phase 1 Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT07485543

• VX-272 dose escalation in healthy adults

  This will test single and multiple increasing doses of the experimental drug VX-272 in healthy adults to see how safe it is and how the body handles it.

  Recruiting Phase 1 Vertex Pharmaceuticals Incorporated · Tempe, Arizona · NCT07437105

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.