A Multi-center 12-week Study of HMS5552 in T2DM

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the safety, tolerability, efficacy and population PK of HMS5552 in type 2 diabetic adult subjects,there will be 5 groups ,4 groups will receive HMS5552,while 1 will receive placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Male & female, 40~75 years old

2. T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone

3. HbA1c 7.5~10.5% at screening and pre-randomization

4. Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization

5. BMI: 19~30kg/m^2 & TG<5.5mmol/L

Exclusion Criteria:

1. T1D，secondary DM, pre-DM

2. kidney diseases or eGFR MDRD<60ml/min/1.73m^2

3. unstable CVDs

4. liver diseases

5. mental or CNS diseases