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

• Status: Completed
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hua Medicine Limited
• Collaborator: Covance
• Treatments: Metformin

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;