Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-101190 | Other Identifier | JAPIC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of saxagliptin administered before breakfast for 14 consecutive days in patients with type 2 diabetes mellitus.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| saxagliptin | Experimental | 5 mg daily for 14days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| saxaglipitin | Drug | oral administration of 5 mg tablet before breakfast for 14 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Concentrations of plasma saxagliptin and BMS-510849 | daily, up to 42days |
| Pharmacodynamics | Plasma DPP4 actyivity Concentrations of blood glucose, C-peptide, insulin and glucagon Plasma active GLP-1 concentration | daily, up to 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety issues | Adverse events, skin symptom findings, blood pressure and pulse rate, body temperature, body weight, hypoglycemic symptoms, 12-lead ECG, clinical laboratory tests, and pregnancy test (in women of childbearing potential only) | daily, up to 42 days |
Not provided
Inclusion Criteria:
Patients who meet all of the following criteria will be included:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyushu Clinical Pharmacology Reserch Clinic | Fukuoka | Japan |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided