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Clinical Trial Details

Trial ID: L6956
Source ID: NCT01611883
Associated Drug: Ezetimibe
Title: A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01611883/results
Conditions: Hypercholesterolemia
Interventions: DRUG: Ezetimibe|DRUG: Placebo
Outcome Measures: Primary: Change in Glycated Hemoglobin (HbA1c) From Baseline, HbA1c is blood marker used to report average blood glucose levels over a prolonged period of time and is reported as a percentage (%). HbA1C was measured at baseline and after 24 weeks of study drug administration., Baseline and Week 24 | Secondary: Change in Glycoalbumin From Baseline, Glycoalbumin is a blood marker used to assess blood glucose control over time and is reported as a percentage (%). Serum glycoalbumin levels were assessed at baseline and after 24 weeks of study drug administration., Baseline and Week 24|Change in Fasting Plasma Glucose (FPG) From Baseline, Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration., Baseline and Week 24|Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes", The Investigator took into account a participant's index of blood glucose control, diabetes medications, and compliance to diet and exercise therapy to assess overall control of the participant's diabetes and to determine if the participant's diabetes worsened. Participants who experienced the AE "Exacerbation of Diabetes " (verbatim term) were recorded., up to 24 weeks|Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes, The percentage of participants who had changes to their medications used to treat their diabetes, other than small changes in insulin dosing (± 5 Units), were reported and summarized., Up to 24 weeks|Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline, LDL-C levels measured at baseline and after 24 weeks of treatment, Baseline and Week 24|Percent Change in Total Cholesterol (TC) From Baseline, TC levels measured at Baseline and after 24 weeks of treatment., Baseline and Week 24|Percent Change in Triglycerides From Baseline, Triglycerides levels measured at baseline and after 24 weeks of treatment., Baseline and Week 24|Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline, HDL-C levels measured at baseline and after 24 weeks of treatment., Baseline and Week 24|Percent Change in Non-HDL-cholesterol From Baseline, Non-HDL-C levels measured at baseline and after 24 weeks of treatment., Baseline and Week 24
Sponsor/Collaborators: Sponsor: Organon and Co
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 152
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2012-07-02
Completion Date: 2014-01-16
Results First Posted: 2014-12-17
Last Update Posted: 2024-05-24
Locations:
URL: https://clinicaltrials.gov/show/NCT01611883