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The purpose of this study is to assess the safety and tolerability of AZD1656 after multiple repeated oral doses in Japanese patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | 3 gradually increasing repeated oral doses of AZD1656 given to 3 groups (6 on active substance in each group) |
|
| B | Placebo Comparator | Placebo oral suspension given to 3 groups (2 on placebo in each group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Three increasing dose-steps with oral suspension, 8 days treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety by assessment of adverse events, BP, pulse rate, plasma glucose, safety laboratory variables and ECG | Blood samples taken repeatedly during 24 hours on study day sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables (AUC, Cmax, tmax, t½, CL/F, Ae and CLR). | Blood samples taken repeatedly during 24 hours on study day sessions | |
| Pharmacodynamic variables (P-Glucose, S-Insulin and S-C-peptide). | 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 | AstraZeneca R&D Mölndal | Study Director |
| Takashi Eto, MD, PhD | PS Clinic, Fukuoka, Japan | Principal Investigator |
| Mitsuyasu Hokamura, MD | HONJO CLINIC II, Tokyo, Japan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fukuoka | Japan | ||||
| Research Site |
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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 |
Placebo oral suspension, 8 days treatment |
|
| Tokyo |
| Japan |
| D004700 | Endocrine System Diseases |