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Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on either pioglitazone or rosiglitazone alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin 50 mg qd + pioglitazone 45 mg qd | Experimental | Vildagliptin 50 mg qd + pioglitazone 45 mg qd for 24 weeks |
|
| Vildagliptin 50 mg bid + pioglitazone 45 mg qd | Experimental | Vildagliptin 50 mg bid + pioglitazone 45 mg qd for 24 weeks |
|
| Vildagliptin placebo + pioglitazone 45 mg qd | Placebo Comparator | Vildagliptin placebo + pioglitazone 45 mg qd for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | Vildagliptin 50 mg tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c after 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in fasting plasma glucose at 24 weeks | ||
| Patients with endpoint HbA1c <7% after 24 weeks | ||
| Patients with reduction in HbA1c >/= to 0.7% after 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|---|---|
| 17300592 | Derived | Garber AJ, Schweizer A, Baron MA, Rochotte E, Dejager S. Vildagliptin in combination with pioglitazone improves glycaemic control in patients with type 2 diabetes failing thiazolidinedione monotherapy: a randomized, placebo-controlled study. Diabetes Obes Metab. 2007 Mar;9(2):166-74. doi: 10.1111/j.1463-1326.2006.00684.x. |
| Label | URL |
|---|---|
| Results for CLAF237A2304 from the Novartis Clinical Trials website | View source |
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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 |
|---|---|
| D000077597 | Vildagliptin |
| C475520 | 1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| pioglitazone | Drug | pioglitazone 45 mg qd |
|
| Placebo | Drug | Vildagliptin matching placebo |
|
| Adverse event profile after 24 weeks of treatment |
| Change from baseline in HbA1c at 24 weeks for patients with high baseline HbA1c vs low baseline HbA1c |
| D004700 | Endocrine System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |