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

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: HMS5552; Other: Placebo

• Registration Number: NCT02561338
• Lead Sponsor: Hua Medicine Limited

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).

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-28
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Results First Submitted: 2018-02-05
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-25
• Last Update Submitted: 2020-02-25
• Results First Posted: 2020-03-10
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HMS5552 dose 1	HMS5552	75mgQD oral administration
HMS5552 dose 2	HMS5552	100mgQD oral administration
Placebo	Placebo	Placebo, BID/QD oral administration
HMS5552 dose 3	HMS5552	50mgBID oral administration
HMS5552 dose 4	HMS5552	75mgBID oral administration

Primary Outcome Measures

Name	Time	Method
After 12-week Treatment, the Change From Baseline in HbA1c	Baseline and 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in 2hPPG	Baseline and 12 weeks	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.
Change From Baseline in FPG	Baseline and 12 weeks

Trial Locations

Locations (1)

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China