Conditions: Diabetes Mellitus, Type 2
Keywords: GKA,T2DM,HMS5552
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 258
Healthy volunteers: no

Brief summary:
This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.

Detailed description:
Glucokinase (GK, also called hexokinase IV or D) can phosphosphorylate glucose to glucose-6-phosphate (G-6-P) in pancreatic β-cells and liver cells, which represents the first step of glucose metabolism. GK also acts as a glucose sensor and exerts a key role in maintaining glucose homeostasis. HMS5552 is a 4th-generation GK agonist or activator (GKA), which was originally licensed from Roche and subsequently developed by Hua Medicine. HMS5552 has been shown to activate GK in pancreatic beta cells, liver and intestinal epithelial cells. It regulates systemic blood glucose through a variety of mechanisms including directly enhancing insulin release (pancreas), inhibiting production of endogenous glucose (liver) and by indirectly promoting GLP-1 release (enteroendocrine L-cells).

Arms:
arm 1: 75mgQD oral administration arm 2: 100mgQD oral administration arm 3: 50mgBID oral administration arm 4: 75mgBID oral administration arm 5: Placebo, BID/QD oral administration

Interventions: intervention 1: HMS5552 intervention 2: HMS5552 intervention 3: HMS5552 intervention 4: HMS5552 intervention 5: Placebo
Intervention descriptions: intervention 1: 75mgQD intervention 2: 100mgQD intervention 3: 50mgBID intervention 4: 75mgBID intervention 5: QD/BID

Protocol document: