Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis

Inclusion criteria

• ✓. Provision of signed and dated informed consent form.
• ✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
• ✓. Male or female, aged ≥18 years on date of consent.
• ✓. Confirmed diagnosis of CF, defined by positive sweat test or CFTR mutation analysis according to CFF diagnostic criteria.
• ✓. Pancreatic insufficiency defined by clinical requirement for pancreatic enzyme replacement.
• ✓. Abnormal glucose tolerance defined by OGTT criteria for EGI, IGT, or CFRD, or diagnosed CFRD.
• ✓. There will be no restriction on enrollment of individuals with CFRD but without fasting hyperglycemia (fasting hyperglycemia is defined as fasting glucose ≥126 mg/dL)
• ✓. For females of reproductive potential: use of highly effective contraception method for the during of study participation; oral contraceptives, intra-uterine devices, Norplant®, Depo- Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.

Exclusion criteria