Boehringer Ingelheim DM2 1218.83
A 24-week, randomized, double-blind, active-controlled, parallel group trial to assess the superiority of oral linagliptin and metformin compared to linagliptin monotherapy in newly diagnosed, treatmentnaïve, uncontrolled Type 2 Diabetes Mellitus patients
| Protocol | 1218.83 |
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| Identifier | 1218.83 Site Number 11011 |
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| UID | 8d447769-721e-4b20-a760-28cfd5eef417 |
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| Status | Done - Archived |
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| Phase | 4 |
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| Category | Diabetes Type 2 / Adult |
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| Launch Year | 2012 |
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| NCT Number | - |
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| Created | 2011-11-23 12:05 |
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| Last Updated | 2011-11-23 12:05 |
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Description
Key Elements: Study drug Linagliptin is a DPP-4 inhibitor (Tradjenta) and Metformin. The objective of this trial is to show the superiority of the initial combination of linagliptin 5 mg + metformin IR over linagliptin 5 mg alone. Study drug administration 3 tablets in the AM and 2 tablets in the PM. All subject will receive active linagliptin. There is a 50% chance the metformin will be placebo. Up to 11 Office Visits (Depending on the length of Metformin titration period) $50 per visit. Body Mass Index of 45 kg/m² or less at Visit 1. HbA1c >8.5% and <12% at Screening.
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