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To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656 suspension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | AZD1656 |
|
| 2 | Active Comparator | Insulin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | Insulin infusion given during 3 hours at one occasion. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic variables | Blood samples taken repeatedly up to 6 hours during study days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables | Blood samples taken repeatedly during 24 hours on study day sessions | |
| Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables) | Taken repeatedly during treatment periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klas Malmberg, MD, PhD, Prof | AstraZeneca R&D Mölndal | Study Director |
| Linda Morrow, 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 |
|---|---|
| D007328 | Insulin |
| C576407 | AZD1656 |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| AZD1656 |
| Drug |
Single dose oral suspension given at one occasion. |
|
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |