A Study of MK3102 in Obese Subjects and in Patients With Type 2 Diabetes (3102-004)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01088711
First received: March 16, 2010
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

This study will test the safety and tolerability of MK3102.


Condition Intervention Phase
Type 2 Diabetes (T2D)
Drug: MK3102
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK3102 in Obese Subjects and in Patients With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Safety and tolerability of MK3102 measured by number of clinical and laboratory adverse experiences [ Time Frame: through 14 days post last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • percent inhibition of target enzyme [ Time Frame: 168 hours post last dose ] [ Designated as safety issue: No ]
  • Active GLP-1 concentrations [ Time Frame: Through 4 hours postdose ] [ Designated as safety issue: No ]
  • Plasma glucose concentrations [ Time Frame: Through 4 hours postdose ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: March 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panel A - Obese Healthy Subjects - MK3102
Obese Healthy Subjects receiving MK3102
Drug: MK3102
once-weekly doses of MK3102 50 mg capsule, for 4 weeks
Placebo Comparator: Panel A - Obese Healthy Subjects - Placebo
Obese Healthy Subjects receiving placebo
Drug: Comparator: Placebo
once-weekly doses of placebo capsule, for 4 weeks
Experimental: Panel B - Obese Patients with Type 2 Diabetes - MK3102
Obese Patients with Type 2 Diabetes receiving MK3102
Drug: MK3102
once-weekly doses of MK3102 50 mg capsule, for 4 weeks
Placebo Comparator: Panel B - Obese Patients with Type 2 Diabetes - Placebo
Obese Patients with Type 2 Diabetes receiving placebo
Drug: Comparator: Placebo
once-weekly doses of placebo capsule, for 4 weeks

  Eligibility

Ages Eligible for Study:   45 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male subjects and female subjects of non-childbearing potential
  • Subject/patient is obese
  • Panel B: Patient has been diagnosed with type 2 diabetes
  • Patient is not actively participating in a weight loss program

Exclusion Criteria:

  • Subject works a night shift
  • Subject has a history of stroke, chronic seizures or major neurological disorder
  • Subject has history of cancer
  • Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication
  • Subject consumes excessive amounts of alcohol or caffeine
  • Subject has participated in a previous MK3102 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: NCT01088711

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: NCT01088711     History of Changes
Other Study ID Numbers: 3102-004, 2010_516, MK-3102-004
Study First Received: March 16, 2010
Last Updated: September 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Type 2 diabetes (T2D)

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

ClinicalTrials.gov processed this record on August 18, 2014