Phase 1
Completed N=56
Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)
Source: ClinicalTrials.gov NCT00972322 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline in the 24-hour Weighted Mean Glucose (WMG) — 11.0; -4.4 mg/dL — p=0.083
Summary
This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted mean glucose (WMG) from baseline than placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the 24-hour Weighted Mean Glucose (WMG) |
11.0; -4.4 | 0.083 |
| PRIMARY Number of Participants Who Experienced Serious or Non-serious Adverse Events |
0; 0; 16; 10 | — |
| PRIMARY Number of Participants Discontinuing Study Drug Due to an AE |
2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subject has a diagnosis of type 2 diabetes and is being treated with diet and exercise alone, a single oral anti-hyperglycemic agent or a combination of two oral anti-hyperglycemic agents
- Subject is willing to follow a weight-maintaining diet and exercise program during the study
- Subject is a nonsmoker or is willing to limit smoking to 10 cigarettes per day while in the clinical research unit
Exclusion Criteria
- Subject has a history of stroke, chronic seizures, or major neurological disorder
- Subject has a history of cancer, except certain skin and cervical cancers or cancer that was successfully treated 10 or more years prior to screening
- Subject has a history of type 1 diabetes
- Subject has used contact lenses within the last 6 months
- Subject has used any lipid-lowering therapy in the last 3 months, except statins, Zetia, or Vytorin
- Subject has more than 3 alcoholic beverages per day
- Subject has more than 6 servings of caffeine a day
- Subject has participated in a previous MK8245 study
Data sourced from ClinicalTrials.gov (NCT00972322). 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.