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
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 April 21, 2014