Glucokinase Activator in Monogenic Diabetes

Exclusion Criteria13

• Body weight <45kg at screening
• Current or planning pregnancy or lactating
• troke or cardiovascular disease within 6 months of recruitment
• severe renal dysfunction (estimated glomerular filtration rate <30mL/min/1.73m2 or renal replacement therapy)
• severe hepatic dysfunction (aspartate transaminase and/or alanine transaminase > 3 times upper limit of normal)
• history of drug abuse or excessive alcohol intake
• severe hypoglycemia within 6 months prior to screening
• anaemia with Hb <10 g/dL at screening
• excessive blood loss >300mL within 1 month of screening
• use of strong or moderate CYP3A4 inhibitors or inducers
• use of sulfonylureas, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 agonists, sodium glucose transporter 2 inhibitors, insulin, thiazolidinediones, acarbose in the 6 weeks prior to randomisation
• use of long-term high-dose corticosteroids at randomisation
• serious concurrent infections at time of screening