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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 on top of insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Dose titration of oral suspension to a tolerable dose in 2-3 dose steps. Investigational product given twice daily for eight days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (AE, BP, pulse, weight, 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 | AstraZeneca R&D Mölndal | Study Director |
| Marcus Hompesch, MD | Profil Institut 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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| Placebo | Drug | Dosing to match AZD1656 |
|
| D004700 | Endocrine System Diseases |