NCT02561338

A Multi-center 12-week Study of HMS5552 in T2DM

A Multi-center, Randomized, Double-blind, Placebo-controlled, 12-week Phase II Study to Evaluate the Safety, Tolerability, Efficacy and Population PK of HMS5552 in Type 2 Diabetic Adult Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: Hua Medicine Limited · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	HMS5552	75mgQD
DRUG	HMS5552	100mgQD
DRUG	HMS5552	50mgBID
DRUG	HMS5552	75mgBID
OTHER	Placebo	QD/BID

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2015-09-28
• Last updated: 2020-03-10
• Results posted: 2020-03-10

Locations

1 site across 1 country: China