Long-term Efficacy and Safety of HMS5552 add-on to Metformin in T2DM Subjects

A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 add-on to Metformin With Additional 28-week Open-label Treatment to Evaluate the Safety in T2DM Subjects

Sponsors

Lead Sponsor: Hua Medicine Limited

Collaborator: Covance

Source Hua Medicine Limited
Brief Summary

This study evaluates the efficacy and safety and population PK of HMS5552 add-on to Metformin in adult type 2 diabetic subjects. There will be 2 groups in the first 24 weeks, one group will receive HMS5552 plus Metformin, while the other group will receive placebo plus Metformin; after 24 weeks, all subjects will receive HMS5552 plus Metformin 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, meanwhile, subjects are treated with Metformin (Glucophage) at 1500mg/day as basic therapy throughout the treatment period. 3 weeks after run-in, eligibility is confirmed with required laboratory tests at -5±2 days prior to randomization. The eligible subjects are randomly assigned to HMS5552 75mg BID group or placebo BID group with ratio 1:1 to receive a 24-week double-blind treatment. Then all subjects receive 28-week open-label treatment of HMS5552 75mg BID add-on to Metformin. After 52-week treatment, all investigational drugs should be discontinued, followed by 1 week for safety evaluation. The dosage of Metformin (Glucophage) should be maintained at 1500 mg/day from run-in period to treatment completion.

Overall Status Recruiting
Start Date October 15, 2017
Completion Date December 31, 2020
Primary Completion Date December 31, 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
The change of HbA1c from baseline at each visit over time, except at Week 24 24 weeks
Incidence of Treatment-Emergent Adverse Events over time 52 weeks
Enrollment 750
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. T2DM and treated with Metformin ≥ 1500mg/day constantly for at least 12 consecutive weeks;

3. 7.5% ≤ HbA1c ≤ 10.0% at screening;

4. 18.5 kg/m2 < BMI < 35.0 kg/m2 at screening;

Exclusion Criteria:

1. Any anti-diabetic therapy other than Metformin within 12 weeks before screening;

2. Received insulin therapy more than 30 days within 1 year before screening;

3. Fasting C-peptide <0.81 ng/ml (0.27 nmol/L) at screening;

4. Medical history of severe hypoglycemia or frequent 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.

5. T1DM;

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Wenying Yang, MD Principal Investigator China-Japan Friendship Hospital
Overall Contact

Last Name: Yi Zhang, MD, PhD

Phone: +86-21-58869997

Email: [email protected]

Location
Facility: Status: Contact: Hua Medicine Limited YI ZHANG, MD,PhD +86-021-58869997 [email protected]
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