Conditions: Diabetes Mellitus Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 796
Healthy volunteers: no

Brief summary:
A study to assess the efficacy and tolerability of ER (Extended Release) niacin/laropiprant versus placebo in Type 2 Diabetes Mellitus patients.

Detailed description:

Arms:
arm 1: Arm 1: One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study. arm 2: Arm 2: stable lipid-modifying regimen, adding Placebo ER niacin/laropiprant in week 4, for the duration of the study.

Interventions: intervention 1: ER niacin/laropiprant intervention 2: Comparator : placebo (unspecified)
Intervention descriptions: intervention 1: One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks. intervention 2: ER niacin/laropiprant Placebo

Protocol document: