Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)
- Registration Number
- NCT01088711
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Placebo Placebo Obese healthy participants receive once-weekly placebo by mouth for 4 weeks (Panel A). T2D Placebo Placebo Obese participants with T2D receive once-weekly placebo by mouth for 4 weeks (Panel B). Healthy Omarigliptin Omarigliptin Obese healthy participants receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel A). T2D Omarigliptin Omarigliptin Obese participants with T2D receive once-weekly omarigliptin 50 mg by mouth for 4 weeks (Panel B).
- Primary Outcome Measures
Name Time Method Number of Participants Withdrawing From Study Therapy Due to an AE Up to Day 22 Number of Participants Experiencing an Adverse Event (AE) Up to Day 36
- Secondary Outcome Measures
Name Time Method Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15 168 hours post-dose on Day 15 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 22 168 hours post dose on Day 22 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 Through 4 hours post dose on Day 21 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 Through 4 hours post dose on Day 21 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 Through 4 hours post dose on Day 21 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.