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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
15
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.
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGUniversity of Pennsylvania Center for Human Phenomic Science (CHPS)
Philadelphia, Pennsylvania, United States
RECRUITINGDrug concentrations (PK; Cmax)
Assessed by the peak glucose during a standardized mixed-meal tolerance test following 7-day administration of study drug
Time frame: 2 months
Glucose tolerance (PD)
Time frame: 2 months
Early-phase insulin secretion
Assessed by insulin secretory rate and
Time frame: 2 months
Glucagon suppression
Glucagon incremental area-under-the-curve (iAUC) analyses during the mixed-meal tolerance test following 7-day administration of study drug. iAUC analyses for GLP-1 and GIP will be assessed as potential effect modifiers.
Time frame: 2 months
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