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FSI delayed until 15 January 2013
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study intends to compare the efficacy and safety of dapagliflozin versus placebo in treatment-naïve subjects with type 2 diabetes who have inadequate glycaemic control with diet and exercise alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | 5mg Oral dose od |
| |
| Dapagliflozin |
| Measure | Description | Time Frame |
|---|---|---|
| change in glycosylated haemoglobin A1c (HbA1c). | From baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| mean change in fasting plasma glucose (FPG) | From baseline to week 24 | |
| mean change in 2- hour postprandial glucose by Mixed Meal Test | From baseline to week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. A. Ramachandran, MD, PhD | Dr. A. Ramachandran's Diabetes Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Hyderabad | Andhra Pradesh | India | |||
| Research Site |
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| Drug |
10 mg Oral dose od |
|
| placebo | Drug | 5/10 mg Oral dose od |
|
| mean change from baseline in fasting plasma glucose (FPG) |
| From baseline to week 1 |
| Vijaywada |
| Andhra Pradesh |
| India |
| Research Site | Ahmedabad | Gujarat | India |
| Research Site | Bangalore | Karnataka | India |
| Research Site | Mysore | Karnataka | India |
| Research Site | Trivandrum | Kerala | India |
| Research Site | Indore | Madhya Pradesh | India |
| Research Site | Mumbai | Maharashtra | India |
| Research Site | Nagpur | Maharashtra | India |
| Research Site | Pune | Maharashtra | India |
| Research Site | Jaipur | Rajasthan | India |
| Research Site | Chennai | Tamil Nadu | India |
| Research Site | Coimbatore | Tamil Nadu | India |
| Research Site | Madurai | Tamil Nadu | India |
| Research Site | Ghaziabad | Uttar Pradesh | India |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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