Long-term Efficacy and Safety of HMS5552 in T2DM Subjects

• Status: Completed
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Hua Medicine Limited
• Collaborator: Tigermed Consulting Co., Ltd

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