N/A
N=93
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)
Dyslipidemia · Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01333436 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48) — 63.4; 41.7 μg/mL x h — p=0.0078
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test Meal (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postprandial Incremental Area Under the Curve From 0-6 Hours (iAUC)[0-6] of Apolipoprotein B-48 (ApoB-48) |
63.4; 41.7 | 0.0078 sig |
| SECONDARY Postprandial Mean ApoB-48 Peak Levels |
24.8; 19.3 | 0.0675 |
| SECONDARY Fasting ApoB-48 Levels |
5.9; 7.3 | 0.1798 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01333436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.