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

NCT00485758 | Completed Phase 3 Results

• 3 other identifiers: 0524A-069MK0524A-0692007_543
• Study Type: interventional
• Target: 796
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetes Mellitus Type 2

Outcome Measures

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

  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 Outcomes (2)

• 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

• 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

Study Arms (2)

1

OTHER

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

2

ACTIVE COMPARATOR

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

Drug: Comparator : placebo (unspecified)

Interventions

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.

Also known as: MK0524A, CORDAPTIVE™, laropiprant (+) niacin

1

Comparator : placebo (unspecified) DRUG

ER niacin/laropiprant Placebo

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (5)

• MacLean A, McKenney J, Scott R, Brinton E, Bays H, Mitchel Y, Paolini J, Giezek H, Vandormael K, Ruck RA, Gibson K, Sisk CM, Maccubbin D. Efficacy and safety of extended release niacin/laropiprant in patients with type 2 diabetes mellitus. Br J Cardiol. 2011;18(1):37-45.

  RESULT

• Bays HE, Brinton EA, Triscari J, Chen E, Maccubbin D, MacLean AA, Gibson KL, Ruck RA, Johnson-Levonas AO, O'Neill EA, Mitchel YB. Extended-release niacin/laropiprant significantly improves lipid levels in type 2 diabetes mellitus irrespective of baseline glycemic control. Vasc Health Risk Manag. 2015 Feb 24;11:165-72. doi: 10.2147/VHRM.S70907. eCollection 2015.

  PMID: 25750540 DERIVED

• Bays HE, Shah A, Lin J, Sisk CM, Dong Q, Maccubbin D. Consistency of extended-release niacin/laropiprant effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 ratio across patient subgroups. Am J Cardiovasc Drugs. 2012 Jun 1;12(3):197-206. doi: 10.2165/11631530-000000000-00000.

  PMID: 22500948 DERIVED

• Bays H, Giezek H, McKenney JM, O'Neill EA, Tershakovec AM. Extended-release niacin/laropiprant effects on lipoprotein subfractions in patients with type 2 diabetes mellitus. Metab Syndr Relat Disord. 2012 Aug;10(4):260-6. doi: 10.1089/met.2012.0005. Epub 2012 Mar 8.

  PMID: 22400810 DERIVED

• Bays H, Shah A, Dong Q, McCrary Sisk C, Maccubbin D. Extended-release niacin/laropiprant lipid-altering consistency across patient subgroups. Int J Clin Pract. 2011 Apr;65(4):436-45. doi: 10.1111/j.1742-1241.2010.02620.x.

  PMID: 21401833 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MK-0524; Niacin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 12, 2015
• Results First Posted: September 11, 2009

Record last verified: 2015-10