Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate Fasting/Postprandial Serum Apolipoprotein B-48 (ApoB-48) Levels in Diabetic Participants With Normal to Moderately High Low Density Lipoprotein-C (LDL-C) Levels (MK-0653A-259 AM1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01333436
Recruitment Status : Completed
First Posted : April 12, 2011
Results First Posted : April 9, 2013
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Dyslipidemia
Hypercholesterolemia
Intervention Other: Test Meal
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diabetic Participants Nondiabetic Participants
Hide Arm/Group Description Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein). Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
Period Title: Overall Study
Started 43 50
Completed 43 50
Not Completed 0 0
Arm/Group Title Diabetic Participants Nondiabetic Participants Total
Hide Arm/Group Description Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein. Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal ( 57% fat, 31% carbohydrate, and 12% protein). Total of all reporting groups
Overall Number of Baseline Participants 43 50 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 50 participants 93 participants
54.0  (11.5) 46.0  (13.6) 49.7  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 50 participants 93 participants
Female
21
  48.8%
24
  48.0%
45
  48.4%
Male
22
  51.2%
26
  52.0%
48
  51.6%
1.Primary Outcome
Title Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)
Hide Description ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.
Time Frame up to 6 hours after Test Meal
Hide Outcome Measure Data
Hide Analysis Population Description
Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.
Arm/Group Title Diabetic Participants Nondiabetic Participants
Hide Arm/Group Description:
Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
Overall Number of Participants Analyzed 42 46
Mean (Standard Deviation)
Unit of Measure: μg/mL x h
63.4  (42.4) 41.7  (30.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diabetic Participants, Nondiabetic Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 21.8
Parameter Dispersion
Type: Standard Deviation
Value: 36.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Postprandial Mean ApoB-48 Peak Levels
Hide Description ApoB-48 levels measured at 1, 2, 3, 4, and 6 hours after the administration of test meal. Peak was the highest ApoB-48 level recorded during this timeframe.
Time Frame up to 6 hours after Test Meal
Hide Outcome Measure Data
Hide Analysis Population Description
Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.
Arm/Group Title Diabetic Participants Nondiabetic Participants
Hide Arm/Group Description:
Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
Overall Number of Participants Analyzed 42 46
Mean (Standard Deviation)
Unit of Measure: μg/mL
24.8  (15.7) 19.3  (11.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diabetic Participants, Nondiabetic Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0675
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 5.5
Parameter Dispersion
Type: Standard Deviation
Value: 13.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Fasting ApoB-48 Levels
Hide Description ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).
Time Frame Baseline (Hour 0)
Hide Outcome Measure Data
Hide Analysis Population Description
Full-Analysis-Set (FAS) population defined as all participants who had valid postprandial ApoB-48 measurements for all specified time points to calculate iAUC.
Arm/Group Title Diabetic Participants Nondiabetic Participants
Hide Arm/Group Description:
Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
Overall Number of Participants Analyzed 42 46
Mean (Standard Deviation)
Unit of Measure: μg/mL
5.9  (3.5) 7.3  (5.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diabetic Participants, Nondiabetic Participants
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1798
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.4
Parameter Dispersion
Type: Standard Deviation
Value: 4.8
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diabetic Participants Nondiabetic Participants
Hide Arm/Group Description Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein). Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
All-Cause Mortality
Diabetic Participants Nondiabetic Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Diabetic Participants Nondiabetic Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diabetic Participants Nondiabetic Participants
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/50 (0.00%) 
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.
Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results for their study site independently. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01333436     History of Changes
Other Study ID Numbers: 0653A-259
First Submitted: March 24, 2011
First Posted: April 12, 2011
Results First Submitted: February 27, 2013
Results First Posted: April 9, 2013
Last Update Posted: May 5, 2017