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The purpose of this study is to compare the 24-hour glucose profiles in diabetic patients treated with metformin following once daily and twice daily oral dosing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | twice daily during 4 days |
|
| 2 | Experimental | once daily during 4 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD1656 | Drug | Oral suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hr glucose (Calculated plasma glucose AUC0-24, change in fasting plasma glucose) | Repeated sampling during the 24 hour period on day -1, 4 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (Adverse events (AEs) during the study, blood pressure (BP), pulse rate, safety laboratory variables (incl. glucose) and investigator's interpretation of electrocardiogram (ECG) | Frequent measurements during the study period | |
| Pharmacokinetic variables (Area under the plasma conc vs. time curve (AUC0-24), maximum plasma conc (Cmax), time to reach maximum plasma conc(tmax), terminal elimination half-life and apparent oral clearance |
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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 |
| Emanuel P DeNoia, M.D | Healthcare Discoveries LLC Icon Development Solutions | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | San Antonio | Texas | 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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| Repeated sampling at pre-specified timepoints on day 4 and 8 |
| Pharmacodynamics (S-Insulin AUC0-24 and C-peptide AUC0-24) | Repeated sampling during the 24 hour period on day -1, 4 and 8 |
| D004700 | Endocrine System Diseases |