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)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01333436
• Collaborator: (none)
• Enrollment: 93
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.8
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

This study will evaluate whether fasting/postprandial serum ApoB-48 levels are increased in diabetic participants compared to nondiabetic participants with the same range of serum LDL-C levels, and whether ApoB-48 levels can be used, along with LDL-C levels, to identify potential cardiovascular disease risk.

Condition or Disease	Intervention/Treatment	Phase
Dyslipidemia; Hypercholesterolemia	Other: Test Meal	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Multicenter, Cross-sectional Study to Evaluate Plasma ApoB-48 Concentration Among Korean Diabetic Patients (With Normal to Moderately High LDL-C Levels)
• Actual Study Start Date: Jul 20, 2011
• Actual Primary Completion Date: May 12, 2012
• Actual Study Completion Date: May 12, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diabetic participants Diabetic participants with normal to moderately high LDL-C	Other: Test Meal; During Visit 2, a test meal will be supplied by the Sponsor of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein), and postprandial blood draws will be done at 1, 2, 3, 4, and 6 hours after the meal.
Experimental: Nondiabetic participants Non-diabetic participants with normal to moderately high LDL-C	Other: Test Meal; During Visit 2, a test meal will be supplied by the Sponsor of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein), and postprandial blood draws will be done at 1, 2, 3, 4, and 6 hours after the meal.

Outcome Measures

Primary Outcome Measures

1. Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48) [up to 6 hours after Test Meal]

   ApoB-48 levels were measured at 1, 2, 3, 4, and 6 hours after the administration of the test meal.

Secondary Outcome Measures

1. Postprandial Mean ApoB-48 Peak Levels [up to 6 hours after Test Meal]

   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.

2. Fasting ApoB-48 Levels [Baseline (Hour 0)]

   ApoB-48 levels measured after at least a 12-hour fast and prior to administration of test meal (Hour 0).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria:

• Participant has an LDL-C ranging from ≥100 mg/dL to <160 mg/dL.

• Patient has a triglyceride (TG) level of ≤500 mg/dL.

Exclusion Criteria:

• Participant treated with a lipid-lowering agent in the 6 weeks prior to Visit 1 (screening period).

• Participant has active liver disease or persistent unexplained serum transaminase elevations (≥2 x the upper limit of normal [ULN])

• Participant has increased creatine kinase (CK) (≥2 x ULN).

• Participant has a history of type 1 diabetes mellitus, ketoacidosis, or gestational diabetes mellitus.

• Participant has a history of alcohol and/or drug abuse.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MSD Korea Ltd.	Seoul		Korea, Republic of	121-705

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01333436
• Other Study ID Numbers: 0653A-259
• First Posted: Apr 12, 2011
• Last Update Posted: Feb 11, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Hypercholesterolemia; Dyslipidemias

Study Results

Participant Flow

Arm/Group Title	Diabetic Participants	Nondiabetic Participants
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

Baseline Characteristics

Arm/Group Title	Diabetic Participants	Nondiabetic Participants	Total
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 Participants	43	50	93
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.0 (11.5)	46.0 (13.6)	49.7 (13.2)
Sex: Female, Male (Count of Participants)
Female	21 48.8%	24 48%	45 48.4%
Male	22 51.2%	26 52%	48 51.6%

Outcome Measures

1. Primary Outcome

Title	Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48)
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

Outcome Measure Data

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
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).
Measure Participants	42	46
Mean (Standard Deviation) [μg/mL x h]	63.4 (42.4)	41.7 (30.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetic Participants, Nondiabetic Participants
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0078
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	21.8
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 36.8
	Estimation Comments

2. Secondary Outcome

Title	Postprandial Mean ApoB-48 Peak Levels
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

Outcome Measure Data

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
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).
Measure Participants	42	46
Mean (Standard Deviation) [μg/mL]	24.8 (15.7)	19.3 (11.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetic Participants, Nondiabetic Participants
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0675
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	5.5
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 13.9
	Estimation Comments

3. Secondary Outcome

Title	Fasting ApoB-48 Levels
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)

Outcome Measure Data

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
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).
Measure Participants	42	46
Mean (Standard Deviation) [μg/mL]	5.9 (3.5)	7.3 (5.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetic Participants, Nondiabetic Participants
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1798
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.4
	Confidence Interval	() 95%; to
	Parameter Dispersion	Type: Standard Deviation; Value: 4.8
	Estimation Comments

Adverse Events

Arm/Group Title	Diabetic Participants		Nondiabetic Participants
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Diabetic Participants		Nondiabetic Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Diabetic Participants		Nondiabetic Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.