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

Phase 3

Completed

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: ER niacin/laropiprant

• Registration Number: NCT00485758
• Lead Sponsor: Merck Sharp & Dohme LLC

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2007-06-12
• Study First Submitted QC: 2007-06-12
• Study First Posted: 2007-06-13
• Study Start: 2007-07
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-08-04
• Results First Submitted QC: 2009-08-04
• Results First Posted: 2009-09-11
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 796

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ER niacin/laropiprant	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.

Primary Outcome Measures

Name	Time	Method
Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Low-density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo	Baseline and 12 Weeks	After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo

Secondary Outcome Measures

Name	Time	Method
Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo	Baseline and 12 Weeks	After 12 weeks of treatment, to assess the increase of high-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo
Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo	Baseline and 12 Weeks	after 12 weeks of treatment, to assess the reduction of triglycerides in patients with Type 2 diabetes when compared to placebo