Conditions: Type 2 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 26
Healthy volunteers: yes

Brief summary:
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).

Detailed description:
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

Arms:
arm 1: Arm A: ER niacin/laropiprant + Placebo to laropiprant arm 2: Arm B: ER niacin + Placebo to laropiprant arm 3: Arm C: laropiprant + Placebo to ER Niacin/laropiprant arm 4: Arm D: Placebo

Interventions: intervention 1: Comparator: ER niacin (+) laropiprant intervention 2: Comparator: ER niacin intervention 3: Comparator: laropiprant intervention 4: Comparator: placebo
Intervention descriptions: intervention 1: ER niacin 2 g/ laropiprant 40 mg daily for 7 days. intervention 2: ER niacin 2 g daily for 7 days. intervention 3: laropiprant 40 mg daily for 7 days. intervention 4: matching placebo tablets for each of the interventions once daily for 7 days

Protocol document: