Phase 1
Completed N=70
A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
Source: ClinicalTrials.gov NCT00511667 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: Participants With Any Clinical Adverse Experience — 51.9; 61.1 percentage of of participants
Summary
A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Any Clinical Adverse Experience |
51.9; 61.1 | — |
| PRIMARY Participants Discontinued Because of Any Clinical Adverse Experience |
1; 0; 0; 0 | — |
| SECONDARY Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941 |
2343.29; 3789.25; 8387.74; 7673.77; 8692.07 | — |
| SECONDARY Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941 |
228.35; 364.96; 841.57; 648.49; 1145.81 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941 |
1.5; 1.0; 1.0; 1.0; 2.0 | — |
| SECONDARY Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941 |
10.4; 11.4; 8.4; 10.1; 11.4 | — |
| SECONDARY Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941 |
26.75; 42.99; 95.07; 76.89; 149.30 | — |
Eligibility Criteria
Inclusion Criteria
- Nonsmoking Male or Female (of non-child bearing potential)
- Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents
- Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more
Exclusion Criteria
- Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist
- Subject is on 3 or more oral anti-diabetes medications
- Subject has a history of type 1 diabetes
- Subject has a diagnosis of glaucoma or is blind
- Subject has had trauma to one or both eyes
Data sourced from ClinicalTrials.gov (NCT00511667). 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.