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

March 16, 2010
September 20, 2013
March 2010
May 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01088711 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of MK3102 in Obese Subjects and in Patients With Type 2 Diabetes (3102-004)
A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK3102 in Obese Subjects and in Patients With Type 2 Diabetes

This study will test the safety and tolerability of MK3102.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes (T2D)
  • Drug: MK3102
    once-weekly doses of MK3102 50 mg capsule, for 4 weeks
  • Drug: Comparator: Placebo
    once-weekly doses of placebo capsule, for 4 weeks
  • Experimental: Panel A - Obese Healthy Subjects - MK3102
    Obese Healthy Subjects receiving MK3102
    Intervention: Drug: MK3102
  • Placebo Comparator: Panel A - Obese Healthy Subjects - Placebo
    Obese Healthy Subjects receiving placebo
    Intervention: Drug: Comparator: Placebo
  • Experimental: Panel B - Obese Patients with Type 2 Diabetes - MK3102
    Obese Patients with Type 2 Diabetes receiving MK3102
    Intervention: Drug: MK3102
  • Placebo Comparator: Panel B - Obese Patients with Type 2 Diabetes - Placebo
    Obese Patients with Type 2 Diabetes receiving placebo
    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
32
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
45 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01088711
3102-004, 2010_516, MK-3102-004
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2013

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