Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

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

Sponsors

Lead Sponsor: Hua Medicine Limited

Collaborator: Tigermed Consulting Co., Ltd

Source Hua Medicine Limited
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.

Overall Status Active, not recruiting
Start Date July 18, 2017
Completion Date December 31, 2020
Primary Completion Date December 30, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in HbA1c 24 weeks
Secondary Outcome
Measure Time Frame
The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline 24 weeks
The change of fasting plasma glucose (FPG) from baseline 24 weeks
The proportion of subjects with HbA1c < 7.0% 24 weeks
Incidence of Treatment-Emergent Adverse Events over time 52 weeks
Enrollment 450
Condition
Intervention

Intervention Type: Drug

Intervention Name: HMS5552

Description: BID Oral administration

Arm Group Label: HMS5552

Other Name: Glucokinase Activator (GKA)

Intervention Type: Drug

Intervention Name: Placebo

Description: BID Oral administration

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dalong Zhu, PhD Principal Investigator The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Location
Facility: Hua Medicine Limited
Location Countries

China

Verification Date

February 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: HMS5552

Type: Experimental

Description: 75mg BID

Label: Placebo

Type: Placebo Comparator

Description: BID

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov