Phase 1
Completed N=32
Evaluation of Omarigliptin (MK-3102) in Obese Participants and in Participants With Type 2 Diabetes (MK-3102-004)
Type 2 Diabetes (T2D)
Source: ClinicalTrials.gov NCT01088711 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Number of Participants Experiencing an Adverse Event (AE) — 12; 2; 4; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Experiencing an Adverse Event (AE) |
12; 2; 4; 2 | — |
| PRIMARY Number of Participants Withdrawing From Study Therapy Due to an AE |
0; 0; 0; 0 | — |
| SECONDARY Percent Inhibition of Dipeptidyl Peptidase-4 (DPP-4) After Day 15 |
91.92; 1.16 | — |
| SECONDARY Percent Inhibition of DPP-4 After Day 22 |
89.62; -8.59 | — |
| SECONDARY WAA Active Glucagon-like Peptide-1 (GLP-1) Concentration |
3.84; 2.0 | — |
| SECONDARY WAA Total GLP-1 Concentration |
2.11; 2.31 | — |
| SECONDARY Plasma Glucose Concentration |
8.34; 20.84 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01088711). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.