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

Hua Medicine

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Placebo; Drug: HMS5552

Study type: Interventional

Funder types: Industry

Identifiers

NCT02561338

HMM0201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 258 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male & female, 40~75 years old
2. T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
3. HbA1c 7.5~10.5% at screening and pre-randomization
4. Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
5. BMI: 19~30kg/m^2 & TG<5.5mmol/L

Exclusion criteria

1. T1D，secondary DM, pre-DM
2. kidney diseases or eGFR MDRD<60ml/min/1.73m^2
3. unstable CVDs
4. liver diseases
5. mental or CNS diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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258 participants in 5 patient groups, including a placebo group

HMS5552 dose 1

Experimental group

Description:

75mgQD oral administration

Treatment:

Drug: HMS5552

Drug: HMS5552

Drug: HMS5552

Drug: HMS5552

HMS5552 dose 2

Experimental group

Description:

100mgQD oral administration

Treatment:

Drug: HMS5552

Drug: HMS5552

Drug: HMS5552

Drug: HMS5552

HMS5552 dose 3

Experimental group

Description:

50mgBID oral administration

Treatment:

Drug: HMS5552

Drug: HMS5552

Drug: HMS5552

Drug: HMS5552

HMS5552 dose 4

Experimental group

Description:

75mgBID oral administration

Treatment:

Drug: HMS5552

Drug: HMS5552

Drug: HMS5552

Drug: HMS5552

Placebo

Placebo Comparator group

Description:

Placebo, BID/QD oral administration

Treatment:

Other: Placebo