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| Name | Class |
|---|---|
| Tigermed Consulting Co., Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMS5552 | Experimental | 75mg BID |
|
| Placebo | Placebo Comparator | BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMS5552 | Drug | BID Oral administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c | The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline | The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline in T2DM subjects after 24-week double-blind treatment | 24 weeks |
| The change of fasting plasma glucose (FPG) from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalong Zhu, PhD | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hua Medicine Limited | Shanghai | Shanghai Municipality | 201203 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000629807 | Dorzagliatin |
| C520311 | glucokinase activator compound 50 |
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| Placebo | Drug | BID Oral administration |
|
The change of fasting plasma glucose (FPG) from baseline in T2DM subjects after 24-week double-blind treatment |
| 24 weeks |
| The proportion of subjects with HbA1c < 7.0% | The HbA1c response rate in T2DM subjects after 24-week double-blind treatment | 24 weeks |
| 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 |
| D004700 | Endocrine System Diseases |