Phase 1
N=24
MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
Diabetes Mellitus, Non-Insulin-Dependent
Bottom Line
View on ClinicalTrials.gov: NCT00791661 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Number of Participants Who Experienced at Least One Adverse Event — 1; 1; 0; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MK-1006 (Drug); Placebo (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced at Least One Adverse Event |
1; 1; 0; 1; 1; 3 | — |
| PRIMARY Number of Participants Who Discontinued Treatment Due to an Adverse Event |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006 |
489; 904; 1900; 2350; 2100; 3820 | — |
| SECONDARY Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006 |
358; 665; 1450; 1720; 1440; 2790 | — |
| SECONDARY Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006 |
37.3; 75.4; 169; 185; 141; 310 | — |
| SECONDARY Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006 |
3.0; 4.0; 3.0; 4.0; 5.0; 4.0 | — |
| SECONDARY Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006 |
18.0; 18.5; 19.1; 18.5; 17.0; 21.2 | — |
| SECONDARY 24-hour Weighted Mean Glucose (WMG) Concentration |
206.2; 197.6; 188.6; 178.0; 165.7; 156.7 | 0.368 |
Summary
A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.
Eligibility Criteria
Inclusion Criteria
- Japanese male or female between 20 to 64 years of age
- Diagnosis of type 2 diabetes
- Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent
Exclusion Criteria
- Subject has a history of type 1 diabetes mellitus
- Subject has a clinical diagnosis of glaucoma
- Subject has donated blood or participated in another clinical study in the past 12 weeks
- Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months
Data sourced from ClinicalTrials.gov (NCT00791661). 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.