Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00972322
First received: September 3, 2009
Last updated: May 14, 2014
Last verified: May 2014

September 3, 2009
May 14, 2014
August 2009
January 2010   (final data collection date for primary outcome measure)
  • Change From Baseline in the 24-hour Weighted Mean Glucose (WMG) [ Time Frame: Baseline and Day 28 ] [ Designated as safety issue: No ]
    The 24-hour WMG is derived from multiple glucose values collected during both fasting and post-meal periods. A "weighted" rather than a "simple" mean is used to avoid overrepresentation of post-meal glucose values. Blood samples for glucose were collected immediately prior to, and after each meal, and overnight and fasting one hour pre-dose.
  • Number of Participants Who Experienced Serious or Non-serious Adverse Events [ Time Frame: Up to Day 31 ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. A serious AE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
  • Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to Day 28 ] [ Designated as safety issue: Yes ]
    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
  • Change from baseline in the 24-hour weighted mean glucose (WMG) [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: No ]
  • Number of participants reporting serious or non-serious adverse events [ Time Frame: Baseline and 4 Weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00972322 on ClinicalTrials.gov Archive Site
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Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)
A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes

This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than placebo.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: MK-8245
    MK-8245 50 mg twice daily for 28 days
  • Drug: Comparator: placebo
    matching placebo to MK-8245 twice daily for 28 days
  • Experimental: MK-8245 50 mg
    MK-8245, 50 mg, twice daily for 28 days
    Intervention: Drug: MK-8245
  • Placebo Comparator: Placebo
    Placebo to MK-8245, 50 mg, twice daily
    Intervention: Drug: Comparator: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
  • Subject is willing to follow a weight-maintaining diet and exercise program during the study
  • Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit

Exclusion Criteria:

  • Subject has a history of stroke, chronic seizures, or major neurological disorder
  • Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
  • Subject has a history of type 1 diabetes
  • Subject has used contact lenses within the last 6 months
  • Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin
  • Subject has more than 3 alcoholic beverages per day
  • Subject has more than 6 servings of caffeine a day
  • Subject has participated in a previous MK8245 study
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00972322
8245-012, MK-8245-012, 2009_655
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

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