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NCT Number: NCT01611883

A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ezetimibe

Drug

10 mg oral dose once daily for 24 weeks

Other names: MK-0653, SCH 058235

Placebo

Drug

Placebo to match ezetimibe orally once daily for 24 weeks.

Primary outcomes

  1. Change in Glycated Hemoglobin (HbA1c) From Baseline

    Time frame: Baseline and Week 24

    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.

Secondary outcomes

  1. Change in Glycoalbumin From Baseline

    Time frame: Baseline and Week 24

    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.

  2. Change in Fasting Plasma Glucose (FPG) From Baseline

    Time frame: Baseline and Week 24

    Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.

  3. Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes"

    Time frame: up to 24 weeks

    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.

  4. Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes

    Time frame: Up to 24 weeks

    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.

  5. Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline

    Time frame: Baseline and Week 24

    LDL-C levels measured at baseline and after 24 weeks of treatment

  6. Percent Change in Total Cholesterol (TC) From Baseline

    Time frame: Baseline and Week 24

    TC levels measured at Baseline and after 24 weeks of treatment.

  7. Percent Change in Triglycerides From Baseline

    Time frame: Baseline and Week 24

    Triglycerides levels measured at baseline and after 24 weeks of treatment.

  8. Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline

    Time frame: Baseline and Week 24

    HDL-C levels measured at baseline and after 24 weeks of treatment.

  9. Percent Change in Non-HDL-cholesterol From Baseline

    Time frame: Baseline and Week 24

    Non-HDL-C levels measured at baseline and after 24 weeks of treatment.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Examination of the Effect of Ezetimibe on Glucose Metabolism - Randomized, Double-blind, Placebo-controlled Study in Type 2 Diabetes Mellitus Patients With Hypercholesterolemia - Phase 4, Protocol No. 367 (Also Known as SCH 58235, P06541)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 5, 2012
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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