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

Hua Medicine Limited258 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

258

Conditions

Diabetes Mellitus, Type 2

Interventions

HMS5552DRUG

75mgQD

HMS5552DRUG

100mgQD

HMS5552DRUG

50mgBID

HMS5552DRUG

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 12 weeks

Secondary Outcomes

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.

Time frame: Baseline and 12 weeks

Change From Baseline in FPG

Time frame: Baseline and 12 weeks

Data from ClinicalTrials.gov

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