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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000518-21 | EudraCT Number |
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This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental | Experimental |
|
| Sitagliptin | Active Comparator | Active comparator (drug) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug | 50mg vildagliptin bid |
| |
| Sitagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin | Fasting Plasma Glucose measured on day 14. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin | Fasting Plasma Glucose on day 14 analyzed descriptively. | 14 days |
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Inclusion Criteria:
Patients with type 2 diabetes 18 to 85 years Metformin monotherapy > 4 weeks HbA1c 6.5 - 9.5%
Exclusion Criteria:
FPG > 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke…)
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Rüdiger Göke, MD | Kirchhain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bad Oeynhausen | 32549 | Germany | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25457473 | Derived | Goke R, Eschenbach P, Dutting ED. Efficacy of vildagliptin and sitagliptin in lowering fasting plasma glucose: Results of a randomized controlled trial. Diabetes Metab. 2015 Jun;41(3):244-7. doi: 10.1016/j.diabet.2014.07.004. Epub 2014 Nov 11. |
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| Drug |
100mg sitagliptin po qd |
|
| Berlin |
| 12347 |
| Germany |
| Novartis Investigative Site | Berlin | 13597 | Germany |
| Novartis Investigative Site | Berlin | 14089 | Germany |
| Novartis Investigative Site | Celle | 29221 | Germany |
| Novartis Investigative Site | Hanover | 30165 | Germany |
| Novartis Investigative Site | Hanover | 30167 | Germany |
| Novartis Investigative Site | Kassel | 34117 | Germany |
| Novartis Investigative Site | Kirchhain | 35274 | Germany |
| Novartis Investigative Site | Lehrte | 31275 | Germany |
| Novartis Investigative Site | Mülheim | 45468 | Germany |
| Novartis Investigative Site | Oberhausen | 46049 | Germany |
| Novartis Investigative Site | Osnabrück | 49080 | Germany |
| Novartis Investigative Site | Potsdam | 14469 | Germany |
| Novartis Investigative Site | Stuttgart | 70378 | Germany |
| 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 |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D011719 | Pyrazines |
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