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CompletedNCT00485758Updated Oct 12, 2015Results posted

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

A Phase 3 interventional study of ER niacin/laropiprant and Comparator : placebo (unspecified) in Diabetes Mellitus Type 2, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-10-12.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
796
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Diabetes Mellitus Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 796 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
796 participants (actual)

Study arms

  • Other
    1

    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

  • Active comparator
    2

    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

  • DrugER niacin/laropiprant

    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

  • DrugComparator : placebo (unspecified)

    ER niacin/laropiprant Placebo

06

What researchers measure

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

    Time frame: Baseline and 12 Weeks

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

    After 12 weeks of treatment, to assess the increase of high-density lipoprotein cholesterol in patients with Type 2 diabetes when compared to placebo

    Time frame: Baseline and 12 Weeks

  2. 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

    Time frame: Baseline and 12 Weeks

07

Results

Posted Sep 11, 2009

Participant flow

First Patient In:13-Aug-2007, Last Patient Last Visit:15-Jan-2009 Ninety-four (94) sites participated: Australia 2 sites; Belgium 7 sites; Canada 6 sites; Ecuador 2 sites; Finland 2 sites; Germany 8 sites; Israel 4 sites; Italy 3 sites; Malaysia 5 sites; New Zealand 4 sites; Portugal 4 sites; Sweden 10 sites; Taiwan 5 sites; United States 32 sites

Participant flow — Overall Study
MilestoneExtended Release Niacin/LaropiprantPlacebo
Started454342
Completed298277
Not completed15665
Withdrew: Adverse event10231
Withdrew: Death01
Withdrew: Lost to follow-up51
Withdrew: Physician decision33
Withdrew: Protocol violation112
Withdrew: Withdrawal by subject3227
Withdrew: Study terminated by sponsor30

Outcome measures

PrimaryPercent 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

Time frame:
Baseline and 12 Weeks
Reported as:
Least squares mean · Percent change at Wk 12 compared to Bl
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
Percent change at Wk 12 compared to BlExtended Release Niacin/LaropiprantPlacebo
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-15.8 (-18.4 to -13.2)2.1 (0.3 to 4.6)
Statistical analysis
  • Extended Release Niacin/Laropiprant vs Placebo · Wilcoxon (Mann-Whitney) · p = <0.001 · Mean difference (final values): -17.9 · 95% CI -21.4 to -14.4Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline low-density lipoprotein cholesterol -by-time interaction.
SecondaryPercent 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

Time frame:
Baseline and 12 Weeks
Reported as:
Least squares mean · Percent change at Wk 12 compared to Bl
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
Percent change at Wk 12 compared to BlExtended Release Niacin/LaropiprantPlacebo
Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in High Density Lipoprotein Cholesterol in Patients With Type 2 Diabetes When Compared to Placebo25.4 (23.4 to 27.5)2.2 (0.6 to 3.8)
Statistical analysis
  • Extended Release Niacin/Laropiprant vs Placebo · Repeated Measures Analysis · p = <0.001 · Mean difference (final values): 23.2 · 95% CI 20.7 to 25.7Study times: 4, 8 and 12 weeks. Terms: treatment-by-time, gender-by-time and baseline high-density lipoprotein cholesterol -by-time interaction.
SecondaryPercent 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

Time frame:
Baseline and 12 Weeks
Reported as:
Median · Percent change at Wk 12 compared to Bl
Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo
Percent change at Wk 12 compared to BlExtended Release Niacin/LaropiprantPlacebo
Percent Change at Week (Wk) 12 Compared to Baseline (Bl) in Triglycerides in Patients With Type 2 Diabetes When Compared to Placebo-22.2 (-25.5 to -18.8)2.3 (-1.6 to 6.2)
Statistical analysis
  • Extended Release Niacin/Laropiprant vs Placebo · ANCOVA · p = <0.001 · Median difference (final values): -23.1 · 95% CI -27.2 to -18.9The median difference between treatments is based on the Hodges-Lehmann estimates of shift with a corresponding distribution-free Confidence Interval based on Wilcoxon's rank

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Extended Release Niacin/Laropiprant—26/449 (5.8%)251/449 (55.9%)
Placebo—24/340 (7.1%)113/340 (33.2%)
Most frequent serious events
Showing 10 of 46
Most frequent serious events
EventExtended Release Niacin/LaropiprantPlacebo
Angina unstableCardiac disorders0/4492/340
Coronary artery diseaseCardiac disorders1/4492/340
Non-cardiac chest painGeneral disorders1/4492/340
Myocardial infarctionCardiac disorders2/4490/340
ErysipelasInfections and infestations2/4491/340
Renal failure acuteRenal and urinary disorders2/4490/340
AnaemiaBlood and lymphatic system disorders0/4491/340
Angina pectorisCardiac disorders0/4491/340
Abdominal herniaGastrointestinal disorders0/4491/340
Gastrooesophageal reflux diseaseGastrointestinal disorders0/4491/340
Most frequent other events
Most frequent other events
EventExtended Release Niacin/LaropiprantPlacebo
FlushingVascular disorders79/44916/340
PruritusSkin and subcutaneous tissue disorders71/4499/340
Blood glucose increasedInvestigations52/44914/340
DiarrhoeaGastrointestinal disorders41/44921/340
NasopharyngitisInfections and infestations33/44925/340
Upper respiratory tract infectionInfections and infestations28/44924/340
RashSkin and subcutaneous tissue disorders26/4495/340
NauseaGastrointestinal disorders24/44912/340
HeadacheNervous system disorders20/44918/340

Baseline characteristics

Age, Continuous
Age, Continuous(years)Extended Release Niacin/LaropiprantPlaceboTotal
Mean62.0 ± 9.362.0 ± 9.462.0 ± 9.3
Sex: Female, Male
Sex: Female, Male(Participants)Extended Release Niacin/LaropiprantPlaceboTotal
Female188126314
Male266216482
Fasting Plasma Glucose
Fasting Plasma Glucose(milligrams/deciliter)Extended Release Niacin/LaropiprantPlaceboTotal
Mean132.0 ± 33.9133.6 ± 32.4132.7 ± 33.3
High-density lipoprotein cholesterol
High-density lipoprotein cholesterol(milligrams/deciliter (mg/dl))Extended Release Niacin/LaropiprantPlaceboTotal
Mean49.93 ± 13.4950.26 ± 13.2350.07 ± 13.37
Low-density lipoprotein cholesterol
Low-density lipoprotein cholesterol(milligrams/deciliter (mg/dl))Extended Release Niacin/LaropiprantPlaceboTotal
Mean87.19 ± 20.5485.22 ± 18.0086.34 ± 19.50
Triglycerides
Triglycerides(milligrams/deciliter (mg/dl))Extended Release Niacin/LaropiprantPlaceboTotal
Median126.00 (32.00 to 628.00)129.00 (39.00 to 509.00)127.00 (32.00 to 628.00)
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • 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.
  • 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. PubMed 25750540 ↗
  • 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. PubMed 22500948 ↗
  • 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. PubMed 22400810 ↗
  • 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. PubMed 21401833 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00485758
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jun 13, 2007
Start date
Jul 2007
Primary completion
Aug 2008
Completion
Aug 2008
Results posted
Sep 11, 2009
Last update
Oct 12, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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