drugset / Trial / NCT01552694

Effectiveness of Sitagliptin for HIV Insulin Resistance and Inflammation

NCT01552694 ↗

Phase 3 Completed 38 enrolled Washington University School of Medicine
RandomizedParallel-groupTriple-blindTreatment

Summary

People living with human immunodeficiency virus infection (HIV) have 2-4fold greater risk for developing diabetes and heart disease than the general population. They need safe and effective treatments that reduce the risk for developing diabetes and heart disease, and improve their quality of life. This project will explore whether a new anti-diabetes medication (Januvia) with a novel mechanism of action reduces inflammation, and improves blood vessel function in HIV infected men and women with several risk factors for developing cardiovascular disease.

Timeline

Start
2012-10
Primary completion
2014-10
Completion
2014-12

Outcome

Mixed primary results

registry analysis (superiority or other test); Sitagliptin vs Placebo; p = 0.006; t-test, 2 sided NCT01552694 ↗

registry analysis (superiority or other test); Sitagliptin vs Placebo; p = 0.24; t-test, 2 sided NCT01552694 ↗

registry analysis (superiority or other test); Sitagliptin vs Placebo; p = 0.78; t-test, 2 sided NCT01552694 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Sitagliptin Small molecule 100 mg Oral