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

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

Official Title
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A Multicenter, Randomized, Double-Blind, Placebo Controlled 36 Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant in Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus Type 2

Intervention / Treatment
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* Drug: ER niacin/laropiprant
* Drug: Comparator : placebo (unspecified)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>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. | Drug: ER niacin/laropiprant<br>* One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks.<br>* Other names: laropiprant (+) niacin;|
| Active Comparator: 2<br>Arm 2: stable lipid-modifying regimen, adding Placebo ER niacin/laropiprant in week 4, for the duration of the study. | Drug: Comparator : placebo (unspecified)<br>* ER niacin/laropiprant Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | After 12 Weeks of treatment, to assess the reduction of low-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo | Baseline and 12 Weeks | 

Secondary Outcome Measures

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