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

Erscheinungsjahr:

2021

Erschienen:

2021

Enthalten in:

ClinicalTrials.gov - (2021) vom: 23. Nov. Zur Gesamtaufnahme - year:2021

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
Diabetes Mellitus
Diabetes Mellitus, Type 2
Medical Condition: Type 2 Diabetes Mellitus
Phase: Phase 3
Recruitment Status: Completed
Study Type: Interventional

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

Study ID:

NCT00790205
0431-082
2008_523
2008-006719-20

Veröffentlichungen zur Studie:

fisyears:

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG000638900