Extended Niacin/Laropiprant in Patients With Type 2 Diabetes (0524A-069)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus Type 2

Treatments: Drug: Comparator : placebo (unspecified); Drug: ER niacin/laropiprant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00485758

0524A-069

MK0524A-069

2007_543

Details and patient eligibility

About

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

Enrollment: 796 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between the ages of 18 to 80 years with Type 2 Diabetes who are on a stable dose of antidiabetic medication for at least 3 months

Exclusion criteria

• Patients taking Cholestin, niacin (>50 mg/day), fibrate therapy, hormonal contraceptives, intermittent Hormone Replacement Therapy, or certain corticosteroids
• Patients with any of the following conditions: active liver disease or kidney disease, poorly controlled high blood pressure, active peptic ulcer, or other heart or blood diseases
• Patients with abnormal laboratory results from a blood test that will be given before starting the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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796 participants in 2 patient groups

1

Other group

Description:

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.

Treatment:

Drug: ER niacin/laropiprant

2

Active Comparator group

Description:

Arm 2: stable lipid-modifying regimen, adding Placebo ER niacin/laropiprant in week 4, for the duration of the study.

Treatment:

Drug: Comparator : placebo (unspecified)