SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis-related Diabetes, Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT06149793

Run by

University of Minnesota

People needed

8

Starts

2024-01-08

Expected to finish

2026-12-31

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.