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The objectives of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus.
This will be a randomized, double-blind and placebo-controlled study with multiple oral doses of HMS5552 given to patients with type 2 diabetes mellitus who never accepted anti-diabetic drug for treatment before.
The primary objective is to characterize the safety and tolerability of HMS5552 following multiple ascending doses in patients with type 2 diabetes mellitus after BID dosing for 8 days.
The secondary objectives include:
A maximum total of 80 patients (10 in each dose group and assuming a maximum of 5~8 dose levels). There will be 8 active and 2 placebo patients in each dose group. The safety, tolerability, pharmacokinetics and pharmacodynamics data after each dose cohort will be reviewed in blinded fashion before escalation to the next dose cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMS5552 dose 1 | Experimental | HMS5552 25~400mg. Oral administration, twice per day. |
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| HMS5552 dose 2 | Experimental | HMS5552 25~400mg. Oral administration, twice per day. |
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| HMS5552 dose 3 | Experimental | HMS5552 25~400mg. Oral administration, twice per day. |
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| HMS5552 dose 4 | Experimental | HMS5552 25~400mg. Oral administration, once per day. |
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| HMS5552 dose 5 | Experimental | HMS5552 25~400mg. Oral administration, twice per day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMS5552 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of HMS5552 will be assessed by adverse event monitoring, physical examinations, 12 lead ECGs, vital sign, and safety laboratory measurements. | up to 15 days after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| The single dose and steady state pharmacokinetics (with food and fasting) of HMS5552 will be described by estimating parameters of AUCinf, AUC0-t, Cmax, Tmax, Ae, T1/2, CL/f, CLr/f, accumulation index and fluctuation index. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dalong ZHU, MD | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
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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 |
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| Placebo |
| Drug |
|
| up to day 8 post-dose |
| The single dose and steady state (fasting and postprandial) pharmacodynamic variables will include maximum absolute and percent change in plasma glucose level, AUC0-4, AUC0-16, AUC16-24, AUC0-24 hr of plasma glucose. | up to 4 hour post-dose and up to 24 hour post-dose |
| Insulin, C-peptide, glucagon and glucagon-like peptide 1 up to 6hr post-dose following single dose and steady state (fasting and postprandial) | up to 6 hour post-dose |
| D004700 | Endocrine System Diseases |