Phase 4
N=152
A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01611883 ↗Enrolled (actual)
152
Serious AEs
4.6%
Results posted
Dec 2014
Primary outcome: Primary: Change in Glycated Hemoglobin (HbA1c) From Baseline — 0.22; 0.14 Percent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ezetimibe (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Glycated Hemoglobin (HbA1c) From Baseline |
0.22; 0.14 | — |
| SECONDARY Change in Glycoalbumin From Baseline |
-0.02; -0.02 | — |
| SECONDARY Change in Fasting Plasma Glucose (FPG) From Baseline |
6.6; 11.4 | — |
| SECONDARY Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes" |
9.3; 7.8 | 0.779 |
| SECONDARY Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes |
9.3; 5.2 | 0.365 |
| SECONDARY Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline |
-22.79; -1.75 | <0.001 sig |
| SECONDARY Percent Change in Total Cholesterol (TC) From Baseline |
-15.01; -1.47 | <0.001 sig |
| SECONDARY Percent Change in Triglycerides From Baseline |
-7.52; 3.83 | 0.025 sig |
| SECONDARY Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline |
3.86; 1.41 | 0.246 |
| SECONDARY Percent Change in Non-HDL-cholesterol From Baseline |
-21.32; -2.25 | <0.001 sig |
Summary
This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the placebo control group.
Eligibility Criteria
Inclusion Criteria
- Have hypercholesterolemia (high cholesterol) and have been diagnosed with type 2 diabetes that is being treated with oral anti-diabetic drugs or insulin or both.
- No change in the medication (drugs, dose and administration) for the treatment of diabetes within previous 12 weeks with exception of small changes in insulin dosing
- No change in diet and exercise therapy within previous 4 weeks
Exclusion Criteria
- Coexisting disease (hemoglobinopathy, hemolytic anemia, etc.) that may affect HbA1c measurement
- Homozygous or heterozygous familial hypercholesterolemia
- Previously received ezetimibe
- Hypercholesterolemia associated with: hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure or pancreatitis
- Hyperlipidemia caused by medication
Data sourced from ClinicalTrials.gov (NCT01611883). 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.