Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-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: May 12, 2016
Last verified: May 2016

March 16, 2010
May 12, 2016
March 2010
May 2010   (final data collection date for primary outcome measure)
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to Day 36 ] [ Designated as safety issue: Yes ]
  • Number of Participants Withdrawing From Study Therapy Due to an AE [ Time Frame: Up to Day 22 ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT01088711 on ClinicalTrials.gov Archive Site
  • Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15 [ Time Frame: 168 hours post-dose on Day 15 ] [ Designated as safety issue: No ]
    Percent DPP-4 inhibition at 168 hours after the Day 15 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.
  • Percent Inhibition of DPP-4 After Day 22 [ Time Frame: 168 hours post dose on Day 22 ] [ Designated as safety issue: No ]
    Percent DPP-4 inhibition at 168 hours after the Day 22 dose (from baseline [pre-dose on Day 1]) was compared in healthy and T2D participants receiving omarigliptin or placebo.
  • WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration [ Time Frame: Through 4 hours post dose on Day 21 ] [ Designated as safety issue: No ]
    Weighted average augmentation (WAA) active GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.
  • WAA Total GLP-1 Concentration [ Time Frame: Through 4 hours post dose on Day 21 ] [ Designated as safety issue: No ]
    WAA total GLP-1 concentration was based on the 0.25, 0.5, 1, 2, and 4 hour timepoints. WAA was calculated as AUC0-4 hrs; this AUC was then divided by the time interval of 4 hours to obtain WAA. Log scale data were then back-transformed to obtain LS means.
  • Plasma Glucose Concentration [ Time Frame: Through 4 hours post dose on Day 21 ] [ Designated as safety issue: No ]
    Post-prandial glucose concentration is presented as a weighted average of the 0.25, 0.5, 1, 2, and 4 hour post-dose time points. Glucose concentration was calculated as area under the curve (AUC) for the 4-hr post-dose time period (AUC0-4 hrs); this AUC was then divided by the time interval of 4 hours to obtain weighted average glucose concentration. Log scale data were then back-transformed to obtain LS means.
  • 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 ]
Not Provided
Not Provided
 
Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-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 omarigliptin. It is hypothesized that administration of once-weekly omarigliptin in obese but otherwise healthy participants, and in obese participants with Type 2 diabetes (T2D) will be sufficiently safe and well tolerated to permit continued clinical investigation.
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: Omarigliptin
    Once-weekly 50 mg capsule
    Other Name: MK-3102
  • Drug: Placebo
    Once-weekly placebo capsule
  • Experimental: Healthy Omarigliptin
    Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A).
    Intervention: Drug: Omarigliptin
  • Placebo Comparator: Healthy Placebo
    Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A).
    Intervention: Drug: Placebo
  • Experimental: T2D Omarigliptin
    Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B).
    Intervention: Drug: Omarigliptin
  • Placebo Comparator: T2D Placebo
    Obese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B).
    Intervention: Drug: Placebo
Addy C, Tatosian D, Glasgow XS, Gendrano IN 3rd, Kauh E, Martucci A, Johnson-Levonas AO, Selverian D, Matthews CZ, Gutierrez M, Wagner JA, Aubrey Stoch S. Pharmacokinetic and Pharmacodynamic Effects of Multiple-dose Administration of Omarigliptin, a Once-weekly Dipeptidyl Peptidase-4 Inhibitor, in Obese Participants With and Without Type 2 Diabetes Mellitus. Clin Ther. 2016 Mar;38(3):516-30. doi: 10.1016/j.clinthera.2015.12.020. Epub 2016 Feb 9.

*   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:

  • obese (body mass index [BMI] ≥30 kg/m² and ≤40 kg/m²) male participants and female participants of non-childbearing potential
  • has been diagnosed with T2D (Panel B)
  • is not actively participating in a weight loss program

Exclusion Criteria:

  • has a history of clinically-significant disease (other than T2D)
  • has a history of cancer
  • has estimated creatinine clearance ≤60 mL/min
  • is unable to refrain from or anticipates the use of any prescription or non-prescription medication
  • consumes excessive amounts of alcohol or caffeine
  • has participated in a previous omarigliptin study
Both
45 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01088711
3102-004
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2016

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