Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes (T2D)
Drug: Omarigliptin
Drug: 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

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

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


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: Healthy Omarigliptin
Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A).
Drug: Omarigliptin
Once-weekly 50 mg capsule
Other Name: MK-3102
Placebo Comparator: Healthy Placebo
Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A).
Drug: Placebo
Once-weekly placebo capsule
Experimental: T2D Omarigliptin
Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B).
Drug: Omarigliptin
Once-weekly 50 mg capsule
Other Name: MK-3102
Placebo Comparator: T2D Placebo
Obese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B).
Drug: Placebo
Once-weekly placebo capsule

  Eligibility

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

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
  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 Director Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01088711     History of Changes
Other Study ID Numbers: 3102-004 
Study First Received: March 16, 2010
Results First Received: September 29, 2015
Last Updated: May 12, 2016
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 December 02, 2016