Text Size

Extended Niacin/Laropiprant in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00485758
First received: June 12, 2007
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
Results First Received: August 4, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus Type 2
Interventions: Drug: ER niacin/laropiprant
Drug: Comparator : placebo (unspecified)

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with Type 2 Diabetes who were not at protocol specified low-density lipoprotein cholesterol goal of <115 milligrams/deciliter at screening, had a 4-week run-in period of lipid modifying therapy. In order to advance to randomization, patients had to meet the low-density lipoprotein cholesterol goal.

Reporting Groups
  Description
Extended Release Niacin/Laropiprant

One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).

No adjustments were made to any lipid modifying regimen established during run-in until Week 12.
Placebo Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.

Participant Flow:   Overall Study
    Extended Release Niacin/Laropiprant     Placebo  
STARTED     454     342  
COMPLETED     298     277  
NOT COMPLETED     156     65  
Adverse Event                 102                 31  
Death                 0                 1  
Lost to Follow-up                 5                 1  
Physician Decision                 3                 3  
Protocol Violation                 11                 2  
Withdrawal by Subject                 32                 27  
Study Terminated by Sponsor                 3                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Extended Release Niacin/Laropiprant

One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).

No adjustments were made to any lipid modifying regimen established during run-in until Week 12.
Placebo Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
Total Total of all reporting groups

Baseline Measures
    Extended Release Niacin/Laropiprant     Placebo     Total  
Number of Participants  
[units: participants]
 		  454     342     796  
Age  
[units: years]
Mean ± Standard Deviation 		  62.0  ± 9.3     62.0  ± 9.4     62.0  ± 9.3  
Gender  
[units: participants]
 		     
Female     188     126     314  
Male     266     216     482  
Fasting Plasma Glucose  
[units: milligrams/deciliter]
Mean ± Standard Deviation 		  132.0  ± 33.9     133.6  ± 32.4     132.7  ± 33.3  
High-density lipoprotein cholesterol  
[units: milligrams/deciliter (mg/dl)]
Mean ± Standard Deviation 		  49.93  ± 13.49     50.26  ± 13.23     50.07  ± 13.37  
Low-density lipoprotein cholesterol  
[units: milligrams/deciliter (mg/dl)]
Mean ± Standard Deviation 		  87.19  ± 20.54     85.22  ± 18.00     86.34  ± 19.50  
Triglycerides  
[units: milligrams/deciliter (mg/dl)]
Median ( Full Range ) 		  126.00  
  ( 32.00 to 628.00 )   		  129.00  
  ( 39.00 to 509.00 )   		  127.00  
  ( 32.00 to 628.00 )  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   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 ]
  Show Outcome Measure 2

3.  Secondary:   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 ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


No publications provided by Merck

Publications automatically indexed to this study:


Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00485758     History of Changes
Other Study ID Numbers: 2007_543, MK0524A-069
Study First Received: June 12, 2007
Results First Received: August 4, 2009
Last Updated: April 20, 2010
Health Authority: United States: Food and Drug Administration