Phase 1
Completed N=16
MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).
Diabetes Mellitus, Non-Insulin-Dependent
Source: ClinicalTrials.gov NCT00754130 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Number of Participants Who Experienced at Least One Adverse Event (AE) — 2; 2; 2; 2 participants
Summary
The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event (AE) |
2; 2; 2; 2; 2 | — |
| PRIMARY Number of Participants Who Discontinued Study Drug Due to an AE |
0; 0; 0; 0; 0 | — |
| SECONDARY Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941 |
754; 1900; 3230; 8700; 883; 2360 | — |
| SECONDARY Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941 |
105; 255; 487; 1340; 128; 292 | — |
| SECONDARY Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941 |
3.5; 6.0; 1.0; 1.0; 1.0; 1.0 | — |
| SECONDARY Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr) |
8.9; 14.6; 27.9; 66.4; 9.5; 26.0 | — |
| SECONDARY Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941 |
5.4; 4.4; 4.3; 3.9; 7.7; 8.3 | — |
| SECONDARY Plasma Pharmacokinetic Parameter: Day 5 to Day 1 Accumulation Ratio for AUC (0-24hr), Cmax, and C24hr |
1.18; 1.28; 1.09; 1.1; 1.21; 1.18 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese Male or Female between 20 to 65 years of age
- Diagnosis of Type 2 Diabetes
- Patient being treated by diet and exercise alone
Exclusion Criteria
- Patient has a history of Type 1 Diabetes
- Patient is being treated with glaucoma medications
- Patient has donated blood or participated in another clinical study in the past 12 weeks
- Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse
Data sourced from ClinicalTrials.gov (NCT00754130). 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.