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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 two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to glimepiride in people with type 2 diabetes not at target blood glucose levels on a sulfonylurea alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAF237 50 mg qd + glimepiride 4 mg qd | Experimental | LAF237 50 mg qd + glimepiride 4 mg qd |
|
| LAF237 50 mg bid + glimepiride 4 mg qd | Experimental | LAF237 50 mg bid + glimepiride 4 mg qd |
|
| LAF237 placebo + glimepiride 4 mg qd | Placebo Comparator | LAF237 placebo + glimepiride 4 mg qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vildagliptin | Drug |
| ||
| Glimepiride |
| 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 |
|---|---|---|---|
| 18284434 | Derived | Garber AJ, Foley JE, Banerji MA, Ebeling P, Gudbjornsdottir S, Camisasca RP, Couturier A, Baron MA. Effects of vildagliptin on glucose control in patients with type 2 diabetes inadequately controlled with a sulphonylurea. Diabetes Obes Metab. 2008 Nov;10(11):1047-56. doi: 10.1111/j.1463-1326.2008.00859.x. Epub 2008 Feb 18. |
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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 |
| C057619 | glimepiride |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Drug |
Glimepiride 4 mg qd |
|
| LAF237 placebo | Drug |
|
| 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 |