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The primary aim of this study is to evaluate the safety and tolerability of AZD1656 in T2DM patients treated with metformin and sulfonylurea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZD1656 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Dose titration of oral suspension of AZD165 during 3 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (AE, BP, pulse, plasma glucose, laboratory variables, weight and ECG | AE will be collected from the time for randomisation until follow-up visit. Safety variables and vital signs will be measured at the pre-entry, during study days -2 to 10 and at the follow-up visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables: (Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F) | Blood samples for analysis of plasma concentrations of AZD1656 will be collected on study days 6 and 9. The samples for analysis of glipizide will be collected on study days -1 and 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klas Malmberg, MD, PhD | AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden | Study Director |
| Marcus Dr. Marcus Hompesch, Dr | Profil Institute for Clinical Research Inc.855 3rd Avenue, Suite 4400Chula VistaCA 91911, USA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Diego | California | United States |
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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 |
|---|---|
| C576407 | AZD1656 |
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| Placebo | Drug | Dose titration of oral suspension of placebo during 3 days given twice daily. Subjects will thereafter be for another 6 days |
|
| Pharmacodynamic variables: 24 h plasma glucose, Insulin | Samples for 24-hour plasma glucose and insulin will be collected on study days -1, 6 and 9. |
| D004700 | Endocrine System Diseases |