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NCT Number: NCT00485758

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

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ER niacin/laropiprant

Drug

One tablet of ER niacin/laropiprant (1g); advancing to ER niacin/laropiprant (2g) at Week 4 for the remainder of the study 36 Weeks.

Other names: MK0524A, CORDAPTIVE™, laropiprant (+) niacin

Comparator : placebo (unspecified)

Drug

ER niacin/laropiprant Placebo

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. 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

    Time frame: 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

  2. Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 13, 2007
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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