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

February 25, 2020 updated by: Hua Medicine Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

258

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HMS5552 dose 1
75mgQD oral administration
Drug: HMS5552
75mgQD
Other Names:
  • GKA
Drug: HMS5552
100mgQD
Other Names:
  • GKA
Drug: HMS5552
50mgBID
Other Names:
  • GKA
Drug: HMS5552
75mgBID
Other Names:
  • GKA
Experimental: HMS5552 dose 2
100mgQD oral administration
Drug: HMS5552
75mgQD
Other Names:
  • GKA
Drug: HMS5552
100mgQD
Other Names:
  • GKA
Drug: HMS5552
50mgBID
Other Names:
  • GKA
Drug: HMS5552
75mgBID
Other Names:
  • GKA
Experimental: HMS5552 dose 3
50mgBID oral administration
Drug: HMS5552
75mgQD
Other Names:
  • GKA
Drug: HMS5552
100mgQD
Other Names:
  • GKA
Drug: HMS5552
50mgBID
Other Names:
  • GKA
Drug: HMS5552
75mgBID
Other Names:
  • GKA
Experimental: HMS5552 dose 4
75mgBID oral administration
Drug: HMS5552
75mgQD
Other Names:
  • GKA
Drug: HMS5552
100mgQD
Other Names:
  • GKA
Drug: HMS5552
50mgBID
Other Names:
  • GKA
Drug: HMS5552
75mgBID
Other Names:
  • GKA
Placebo Comparator: Placebo
Placebo, BID/QD oral administration
Other: Placebo
QD/BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
After 12-week Treatment, the Change From Baseline in HbA1c
Time Frame: 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.
Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 2hPPG
Time Frame: 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.
Baseline and 12 weeks
Change From Baseline in FPG
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hua Medicine Limited

Collaborators

Tigermed Consulting Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 28, 2015

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMM0201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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