Type 2 Diabetes Mellitus Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover Study to Evaluate the Effects of ER Niacin/Laropiprant, Laropiprant, ER Niacin, and Placebo on Urinary Prostanoid Metabolites in Subjects With Type 2 Diabetes
The purpose of this study is to evaluate the potential effects of ER niacin/laropiprant, ER niacin, laropiprant, and placebo over the course of seven days on urinary levels of a specific metabolite (which is a marker of in vivo platelet reactivity).
Subjects will receive 1 of 4 treatments per period and will eventually receive all 4
treatments:
Treatment A: ER niacin 2g/laropiprant 40 mg daily + Placebo to laropiprant for 7 days
Treatment B: ER niacin 2 g daily + Placebo to laropiprant for 7
days
Treatment C: laropiprant 40 mg daily + Placebo to ER niacin/laropiprant for 7 days
Treatment D: placebo daily for 7 days. There will be at least a 7-day interval between
dosing on Day 7 of a period and dosing on Day 1 of the subsequent period
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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