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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01611883
First received: June 1, 2012
Last updated: December 9, 2014
Last verified: December 2014

June 1, 2012
December 9, 2014
July 2012
January 2014   (final data collection date for primary outcome measure)
Change in Glycated Hemoglobin (HbA1c) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
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.
Change in Glycosylated Hemoglobin (HbA1c) from Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01611883 on ClinicalTrials.gov Archive Site
  • Change in Glycoalbumin From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
    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.
  • Change in Fasting Plasma Glucose (FPG) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
    Plasma glucose levels were assessed after an overnight fast at baseline and after 24 weeks of study drug administration.
  • Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes" [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    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.
  • Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    LDL-C levels measured at baseline and after 24 weeks of treatment
  • Percent Change in Total Cholesterol (TC) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    TC levels measured at Baseline and after 24 weeks of treatment.
  • Percent Change in Triglycerides From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Triglycerides levels measured at baseline and after 24 weeks of treatment.
  • Percent Change in High-density Lipoprotein Cholesterol (HDL-C) From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    HDL-C levels measured at baseline and after 24 weeks of treatment.
  • Percent Change in Non-HDL-cholesterol From Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
    Non-HDL-C levels measured at baseline and after 24 weeks of treatment.
  • Change in Glycoalbumin from Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
  • Change in Fasting Plasma Glucose (FPG) from Baseline [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: Yes ]
  • Percent Change in Low-density Lipoprotein (LDL) Cholesterol from Baseline [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypercholesterolemia
  • Drug: Ezetimibe
    10 mg oral dose once daily for 24 weeks
    Other Names:
    • MK-0653
    • SCH 058235
  • Drug: Placebo
    Placebo to match ezetimibe orally once daily for 24 weeks.
  • Experimental: Ezetimibe
    10 mg oral dose once daily for 24 weeks
    Intervention: Drug: Ezetimibe
  • Placebo Comparator: Placebo
    Placebo to match ezetimibe orally once daily for 24 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT01611883
P06541, MK-0653-367
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP