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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2006-001110-33 |
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The purpose of this study is to investigate the safety of YM543 in type 2 Diabetes Mellitus patients and to investigate whether this study drug is effective in these patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Dose 1 |
|
| 2 | Experimental | Dose 2 |
|
| 3 | Experimental | Dose 3 |
|
| 4 | Experimental | Dose 4 |
|
| 5 | Active Comparator |
| |
| 6 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YM543 | Drug | Oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (adverse events; biochemical, hematological and urine analysis tests; vital signs, 12-lead ECG, physical examination) | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and pharmacodynamics (change in HbA1c and fasting plasma glucose; change in urinary glucose excretion; plasma levels of YM543; C-peptide, insulin, fructosamine, non-esterified fatty acids, triglyceride, cholesterol-panel) | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Europe B.V. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4 Sites | Moscow | Russia | ||||
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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 |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Metformin |
| Drug |
Oral |
|
| Placebo | Drug | oral |
|
| Nizhny Novgorod |
| Russia |
| Petrozavodsk | Russia |
| 10 Sites | Saint Petersburg | Russia |
| Samara | Russia |
| Yekaterinburg | Russia |
| D004700 | Endocrine System Diseases |