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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561338
• Other study ID #: HMM0201
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2020
• Source: Hua Medicine Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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 a-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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• HMS5552
75mgQD
• HMS5552
100mgQD
• HMS5552
50mgBID
• HMS5552
75mgBID

Other:
• Placebo
QD/BID

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Hua Medicine Limited	Tigermed Consulting Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	After 12-week Treatment, the Change From Baseline in HbA1c	Assess the percentage of Hemoglobin A1c (HbA1c) changes at week 12. In the group HMS5552 dose3, a subject without follow-up data for HbA1c available was excluded. And in the group HMS5552 dose4, two subjects without follow-up data for HbA1c available were excluded. So the overall number of baseline participants is not consistent with numbers provided in any of the rows in the participant flow module.	Baseline and 12 weeks
Secondary	Change From Baseline in 2hPPG	Using a standard meal tolerance test, to assess 2-h postprandial glucose (2hPPG). In this test, subjects were received meals standardised by China National Cereals, which supplied by Oils and Foodstuffs Corporation and contained 353 kcal, 75 g carbohydrate, 1.48 g fat, and 8.0 g protein. Collect the blood samples to detect blood glucose 2 hours after starting the meal.	Baseline and 12 weeks
Secondary	Change From Baseline in FPG		Baseline and 12 weeks