Status:
ACTIVE_NOT_RECRUITING
SGLT2 Inhibitor Therapy in Cystic Fibrosis-related Diabetes
Lead Sponsor:
University of Minnesota
Conditions:
Cystic Fibrosis-related Diabetes
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
The overall goal of this proposal is to collect pilot data for safety and feasibility metrics to support a future larger randomized controlled trial. In this study, we will examine the safety and tole...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06149793
Start Date
December 30 2023
End Date
December 31 2025
Last Update
September 17 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455