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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141073
• Other study ID #: HMM0302
• Status: Completed
• Phase: Phase 3
• Start date: October 15, 2017
• Est. completion date: February 28, 2021

Study information

• Verified date: February 2021
• Source: Hua Medicine Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 767
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• HMS5552
BID oral administration
• Placebo
BID oral administration

Locations

Country	Name	City	State
China	Hua Medicine Limited	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Hua Medicine Limited	Covance

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c	The change of HbA1c from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment	24 weeks
Secondary	The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline	The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment	24 weeks
Secondary	The change of fasting plasma glucose (FPG) from baseline	The change of fasting plasma glucose (FPG) from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment	24 weeks
Secondary	The proportion of subjects with HbA1c < 7.0%	HbA1c response rate by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment	24 weeks
Secondary	The change of HbA1c from baseline at each visit over time, except at Week 24	The change of HbA1c from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects at each visit over time, except at Week 24	24 weeks
Secondary	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).	52 weeks