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Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HMS5552
Placebo
Sponsored by
Hua Medicine Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring GKA, T2DM, HMS5552, monotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female, aged 18~75 years old
  2. naive T2DM 3.7.5% ≤ HbA1c ≤ 11.0% at screening 4.18.5 kg/m2 < BMI < 35.0 kg/m2 at screening;

Exclusion Criteria:

  1. T1DM
  2. Fasting C-peptide <1.0 ng/ml (0.33 nmol/L) at screening
  3. Medical history of severe hypoglycemia, diabetic ketoacidosis, diabetes lactic acidosis or hyperosmotic nonketotic diabetic coma, severe cardio-cerebrovascular,unstable or rapidly progressive kidney disease, active liver diseases,diagnosed mental disease,etc

Sites / Locations

  • Hua Medicine Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HMS5552

Placebo

Arm Description

75mg BID

BID

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c
The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment

Secondary Outcome Measures

The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline
The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline in T2DM subjects after 24-week double-blind treatment
The change of fasting plasma glucose (FPG) from baseline
The change of fasting plasma glucose (FPG) from baseline in T2DM subjects after 24-week double-blind treatment
The proportion of subjects with HbA1c < 7.0%
The HbA1c response rate in T2DM subjects after 24-week double-blind treatment
Incidence of Treatment-Emergent Adverse Events over time
including incidence of adverse events, incidence of hypoglycemic events, physical examination, vital signs, 12-lead ECG, clinical laboratory examinations (routine blood test, blood biochemistry and routine urine test).

Full Information

First Posted
May 30, 2017
Last Updated
August 24, 2021
Sponsor
Hua Medicine Limited
Collaborators
Tigermed Consulting Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03173391
Brief Title
Long-term Efficacy and Safety of HMS5552 in T2DM Subjects
Official Title
A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 With Additional 28-week Open-label Treatment to Evaluate the Safety of HMS5552 Alone in T2DM Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
July 18, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hua Medicine Limited
Collaborators
Tigermed Consulting Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the efficacy and safety and population PK of HMS5552 as monotherapy in adult type 2 diabetic subjects, there will be 2 groups in the first 24 weeks, one group will receive HMS5552 , while the other group will receive placebo ; after 24 weeks, all subjects will receive HMS5552 for 28 weeks.
Detailed Description
This study is a phase III study in subjects with T2DM. As designed, the study will start with a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for screening eligible subjects. The eligible subjects are randomly assigned to HMS5552 75mg BID group or placebo BID group with ratio 2:1 to receive a 24-week double-blind treatment. Then all subjects receive 28-week open-label treatment of HMS5552 75mg BID . After 52-week treatment, all investigational drugs should be discontinued, followed by 1 week for safety evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
GKA, T2DM, HMS5552, monotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
463 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HMS5552
Arm Type
Experimental
Arm Description
75mg BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
BID
Intervention Type
Drug
Intervention Name(s)
HMS5552
Other Intervention Name(s)
Glucokinase Activator (GKA)
Intervention Description
BID Oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
BID Oral administration
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Description
The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline
Description
The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline in T2DM subjects after 24-week double-blind treatment
Time Frame
24 weeks
Title
The change of fasting plasma glucose (FPG) from baseline
Description
The change of fasting plasma glucose (FPG) from baseline in T2DM subjects after 24-week double-blind treatment
Time Frame
24 weeks
Title
The proportion of subjects with HbA1c < 7.0%
Description
The HbA1c response rate in T2DM subjects after 24-week double-blind treatment
Time Frame
24 weeks
Title
Incidence of Treatment-Emergent Adverse Events over time
Description
including incidence of adverse events, incidence of hypoglycemic events, physical examination, vital signs, 12-lead ECG, clinical laboratory examinations (routine blood test, blood biochemistry and routine urine test).
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged 18~75 years old naive T2DM 3.7.5% ≤ HbA1c ≤ 11.0% at screening 4.18.5 kg/m2 < BMI < 35.0 kg/m2 at screening; Exclusion Criteria: T1DM Fasting C-peptide <1.0 ng/ml (0.33 nmol/L) at screening Medical history of severe hypoglycemia, diabetic ketoacidosis, diabetes lactic acidosis or hyperosmotic nonketotic diabetic coma, severe cardio-cerebrovascular,unstable or rapidly progressive kidney disease, active liver diseases,diagnosed mental disease,etc
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalong Zhu, PhD
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hua Medicine Limited
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201203
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

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