Clinical Trial Details
| Trial ID: | L5856 |
| Source ID: | NCT01162876 |
| Associated Drug: | Saxaglipitin |
| Title: | A Clinical Pharmacology Study of Saxagliptin in Patients With Type 2 Diabetes Mellitus |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | NO |
| Results: | |
| Conditions: | Diabetes |
| Interventions: | DRUG: saxaglipitin |
| Outcome Measures: | Primary: 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 | Secondary: 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 |
| Sponsor/Collaborators: | Sponsor: Kyowa Kirin Co., Ltd. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 20 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER |
| Start Date: | 2010-07 |
| Completion Date: | 2010-11 |
| Results First Posted: | |
| Last Update Posted: | 2017-03-09 |
| Locations: | Kyushu Clinical Pharmacology Reserch Clinic, Fukuoka, Japan |
| URL: | https://clinicaltrials.gov/show/NCT01162876 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
|---|