Michael R. Rickels, MD, MS
This study is designed to determine the pharmacokinetic and pharmacodynamic response of dorzagliatin 50 mg twice daily following 7-day administration in individuals with pancreatic insufficient cystic fibrosis and abnormal glucose tolerance when compared to randomized, double-blind 7-day administration of placebo in a cross-over fashion. We hypothesize that dorzagliatin administration will result in significant drug concentrations and improved glucose tolerance, early-phase insulin secretion, glucagon suppression, and hepatic glycogen storage assessed during a standardized mixed-meal tolerance test.
Inclusion Criteria: 1. Provision of signed and dated informed consent form. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female, aged ≥18 years on date of consent. 4. Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria. 5. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement. 6. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD. 7. There will be no restriction on enrollment…
Randomized, double-blind, cross-over study of Dorzagliatin 50 mg orally twice daily for 7 days compared to matched-placebo orally twice daily for 7 days.
Randomized, double-blind, cross-over study of Dorzagliatin 50 mg orally twice daily for 7 days compared to matched-placebo orally twice daily for 7 days.
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