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The study will assess the incidence of Hypoglycemia: Percent of patients presenting no hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental |
| |
| other Oral Antidiabetic Drug in a different therapeutic class | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug |
| ||
| "Usual Care" |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients in each of the two treatment groups presenting no hypoglycemia (confirmed events with SMBG and severe episodes) after 24 wk of randomized therapy added to their ongoing metformin background therapy. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of patients reaching their therapeutic goal | 24 weeks | |
| Percent of patients with success of primary EP (no confirmed/severe hypoglycemia) and reaching their therapeutic goal | 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 Investigative Site | Armentières | 59208 | France | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22996038 | Result | Penfornis A, Bourdel-Marchasson I, Quere S, Dejager S. Real-life comparison of DPP4-inhibitors with conventional oral antidiabetics as add-on therapy to metformin in elderly patients with type 2 diabetes: the HYPOCRAS study. Diabetes Metab. 2012 Dec;38(6):550-7. doi: 10.1016/j.diabet.2012.08.003. Epub 2012 Sep 18. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Glycemic control assessed by A1C, and the mean of 6 Points self-monitoring of blood glucose (SMBG) at baseline and after 24 weeks. |
| 24 weeks |
| Brest |
| 29200 |
| France |
| Novartis Investigative Site | Caen | 14000 | France |
| Novartis Investigative Site | Creil | 60100 | France |
| Novartis Investigative Site #2 | Paris | 75012 | France |
| Novartis Investigative Site | Paris | 75020 | France |
| Novartis Investigative Site | Pau | 64000 | France |
| Novartis Investigative Site | Saint-Jean-de-la-Ruelle | 45140 | France |
| Novartis Investigative Site | Strasbourg | 67000 | France |
| Novartis Investigative Site | Strasbourg | France |
| Novartis Investigative Site | Toulouse | 31200 | France |
| Novartis Investigative Site | Tours | 37000 | France |
| Novartis Investigative Site | Versailles | 78000 | France |
| Novartis Investigative Site | VĂ©nissieux | 69200 | France |
| Novartis Investigative Site #2 | VĂ©nissieux | France |
| D006571 |
| Heterocyclic Compounds |