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Sitagliptin Cardiovascular Outcomes Study (MK-0431-082)

NCT00790205 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14671

Last updated 2021-11-23

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Sitagliptin

Sitagliptin, one 50 mg or one 100 mg tablet (dose dependant on renal function) orally, once daily.

DRUG

Placebo

Placebo tablet matching the 50 mg or 100 mg sitagliptin tablet, orally, once daily.

Sponsors & Collaborators

  • Duke Clinical Research Institute, Oxford Diabetes Trials Unit

    collaborator UNKNOWN

  • Merck Sharp & Dohme LLC

    lead INDUSTRY

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-10
Primary Completion
2015-03-30
Completion
2015-03-30

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00790205 on ClinicalTrials.gov