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The purpose of this study is to assess safety and tolerability of AZD1656 after multiple repeated oral doses in patients with type 2 diabetes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 3 (alt.4) gradually increasing repeated oral doses of AZD1656 given to 3 (alt.4) groups (6 on active and 2 on placebo in each group) |
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| 2 | Experimental | Oral dose of AZD1656 titrated during 3 days to a tolerable dose (15 on active and 5 on placebo) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Dose titration to 3 (alt 4) increasing dose-steps with oral suspension, 8 days treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG) | Blood samples taken repeatedly during 24 hours on study day sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables | Blood samples taken repeatedly during 24 hours on study day sessions | |
| Pharmacodynamic variables | Blood samples taken repeatedly during 24 hours on study day sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klas Malmberg, MD, Phd, Prof | AstraZeneca R&D Mölndal, SE-431 83 Mölndal, Sweden | Study Director |
| Marcus Hompesch, MD | Profil Institute for Clinical Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Chula Vista | 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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| AZD1656 | Drug | Dose titration of oral suspension to a tolerable dose, 1 month treatment |
|
| D004700 | Endocrine System Diseases |