SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amir Moheet
• Treatments: Empagliflozin; Sodium-Glucose Transporter 2 Inhibitors

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)