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
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: MK-8245
Drug: Comparator: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-Controlled Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacokinetics of MK-8245 in Subjects With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Enrollment: 56
Study Start Date: August 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-8245 50 mg
MK-8245, 50 mg, twice daily for 28 days
Drug: MK-8245
MK-8245 50 mg twice daily for 28 days
Placebo Comparator: Placebo
Placebo to MK-8245, 50 mg, twice daily
Drug: Comparator: placebo
matching placebo to MK-8245 twice daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972322

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00972322     History of Changes
Other Study ID Numbers: 8245-012, MK-8245-012, 2009_655
Study First Received: September 3, 2009
Results First Received: May 14, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014