StudyFinder
Efficacy and safety of SGLT2 inhibitor therapy in overweight and obese subjects with cystic fibrosis-related diabetes: a pilot study
Recruiting
In this study, we will examine the safety and tolerability of Sodium glucose co-transporter 2 inhibitor (SGLT2i) (generic name: empagliflozin) for patients who are overweight/obese and have been diagnosed with Cystic Fibrosis Related Diabetes (CFRD).
Male or Female
18 years and over
Inclusion Criteria:
• 18 years or older
• diagnosis of cystic fibrosis related diabetes (CFRD)
• BMI >25 kg/m2
• woman who could become pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study
Exclusion Criteria:
• acute respiratory exacerbation requiring IV antibiotics or systemic glucocorticoids within prior 4 weeks
• less than 12 weeks since start of a new CFTR corrector/modulator therapy
• type 1 diabetes
• history of diabetic ketoacidosis
• history of recurrent genital or urinary tract infections
• women who are pregnant or breastfeeding
• history of eating disorder
• there are additional exclusion criteria (study staff will review)
Drug: Empagliflozin, Other: Placebo Control
Rare Diseases, Diabetes & Endocrine
CF, CFRD, Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Diabetes
Catherine Larson - sund0033@umn.edu
Amir Moheet
PHASE2
STUDY00019241
See this study on ClinicalTrials.gov