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This study is designed to evaluate, in a primary care setting, the safety and efficacy of vildaglipgtin as add on therapy to metformin relative to TZD added to metformin in patients with type 2 diabetes inadequately controlled by metformin alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Vildagliptin 100mg + Met |
|
| TZD | Active Comparator | TZD + metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug | vildagliptin as add-on to metformin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HemoglobinA1c (HbA1c) | after 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight | after 12 weeks of treatment | |
| Change from baseline in fasting plasma glucose (FPG) | after 12 weeks of treatment | |
| Incidence of prespecified adverse events while on treatment with study drug |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Pharmaceuticals | East Hanover | New Jersey | 07936 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19614942 | Result | Blonde L, Dagogo-Jack S, Banerji MA, Pratley RE, Marcellari A, Braceras R, Purkayastha D, Baron M. Comparison of vildagliptin and thiazolidinedione as add-on therapy in patients inadequately controlled with metformin: results of the GALIANT trial--a primary care, type 2 diabetes study. Diabetes Obes Metab. 2009 Oct;11(10):978-86. doi: 10.1111/j.1463-1326.2009.01080.x. Epub 2009 Jul 13. |
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| thiazolidinedione (TZD) | Drug | TZD add-on to metformin |
|
|
| 12 week treatment duration |
| 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 |
|---|---|
| D000077597 | Vildagliptin |
| C089946 | 2,4-thiazolidinedione |
| D000077205 | Pioglitazone |
| D000077154 | Rosiglitazone |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
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