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The study will assess glycemic variability and optimized glycemic control in T2DM patients treated with a DPP-4 inhibitor as add-on therapy to metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vildagliptin | Experimental |
| |
| Sitagliptin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin | Drug |
| ||
| Sitagliptin |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic variability assessed by MAGE (Mean Amplitude of Glycemic Excursion) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control assessed through CSGM | 8 weeks | |
| Glycemic control assessed by A1C, FPG, PPG and the mean of 6 points self-monitoring of blood glucose (SMBG) at baseline and after 8 weeks | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Bondy | France | ||||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22809630 | Derived | Guerci B, Monnier L, Serusclat P, Petit C, Valensi P, Huet D, Raccah D, Colette C, Quere S, Dejager S. Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study. Diabetes Metab. 2012 Oct;38(4):359-66. doi: 10.1016/j.diabet.2012.06.001. Epub 2012 Jul 17. | |
| 22775317 |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| 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 |
| D000068900 | Sitagliptin Phosphate |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Unrecognized hypoglycemic periods recorded by CSGM, frequency and duration | 8 weeks |
| Corbeil |
| France |
| Investigative Site | Marseille | France |
| Investigative Site | Nancy | France |
| Investigative Site | Paris | France |
| Investigative Site | Toulouse | France |
| Investigative Site | Vénissieux | France |
| Monnier L, Colette C, Comenducci A, Vallee D, Dejager S. Add-on therapies to metformin in type 2 diabetes: what modulates the respective decrements in postprandial and basal glucose? Diabetes Technol Ther. 2012 Oct;14(10):943-50. doi: 10.1089/dia.2012.0045. Epub 2012 Jul 9. |
| D006571 |
| Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D011719 | Pyrazines |