Long-term Efficacy and Safety of HMS5552 in T2DM Subjects
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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. The eligible subjects are randomly assigned to HMS5552 75mg BID group or placebo BID group with ratio 2:1 to receive a 24-week double-blind treatment. Then all subjects receive 28-week open-label treatment of HMS5552 75mg BID . After 52-week treatment, all investigational drugs should be discontinued, followed by 1 week for safety evaluation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HMS5552 75mg BID |
Drug: HMS5552
BID Oral administration
Other Names:
|
| Placebo Comparator: Placebo BID |
Drug: Placebo
BID Oral administration
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in HbA1c [24 weeks]
The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment
Secondary Outcome Measures
- The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline [24 weeks]
The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline in T2DM subjects after 24-week double-blind treatment
- The change of fasting plasma glucose (FPG) from baseline [24 weeks]
The change of fasting plasma glucose (FPG) from baseline in T2DM subjects after 24-week double-blind treatment
- The proportion of subjects with HbA1c < 7.0% [24 weeks]
The HbA1c response rate in T2DM subjects after 24-week double-blind treatment
- Incidence of Treatment-Emergent Adverse Events over time [52 weeks]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female, aged 18~75 years old
-
naive T2DM 3.7.5% ≤ HbA1c ≤ 11.0% at screening 4.18.5 kg/m2 < BMI < 35.0 kg/m2 at screening;
Exclusion Criteria:
-
T1DM
-
Fasting C-peptide <1.0 ng/ml (0.33 nmol/L) at screening
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hua Medicine Limited | Shanghai | Shanghai | China | 201203 |
Sponsors and Collaborators
- Hua Medicine Limited
- Tigermed Consulting Co., Ltd
Investigators
- Principal Investigator: Dalong Zhu, PhD, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HMM0301