Sitagliptin Cardiovascular Outcomes Study (MK-0431-082) : TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint..
Medienart: |
Klinische Studie |
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Erscheinungsjahr: |
2021 |
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Erschienen: |
2021 |
Enthalten in: |
ClinicalTrials.gov - (2021) vom: 23. Nov. Zur Gesamtaufnahme - year:2021 |
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Sprache: |
Englisch |
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Links: |
Volltext [kostenfrei] |
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Themen: |
610 |
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Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: November 13, 2008, Last downloaded: ClinicalTrials.gov processed this data on December 06, 2021, Last updated: December 08, 2021 |
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fisyears: |
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Förderinstitution / Projekttitel: |
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PPN (Katalog-ID): |
CTG000638900 |
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520 | |a This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint. | ||
650 | 2 | |a Diabetes Mellitus | |
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650 | 4 | |a Medical Condition: Type 2 Diabetes Mellitus | |
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650 | 4 | |a Phase: Phase 3 | |
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