MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).
A Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 in Japanese Patients With Type 2 Diabetes
3 other identifiers
interventional
16
0 countries
N/A
Brief Summary
The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2008
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 16, 2008
CompletedFirst Posted
Study publicly available on registry
September 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedResults Posted
Study results publicly available
October 3, 2012
CompletedMarch 12, 2015
February 1, 2015
1 month
September 16, 2008
August 31, 2012
February 23, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Up to 14 days after last dose of study drug
Number of Participants Who Discontinued Study Drug Due to an AE
An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product. Participants were monitored for occurrence AEs for up to 8 days after last dose of study drug during Period 1 and for up to 14 days after last dose of study drug during Period 2.
Up to 14 days after last dose of study drug
Secondary Outcomes (6)
Plasma Pharmacokinetic Parameter: Area Under the Concentration-time Curve (AUC)(0-24hr) of MK-0941
Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Maximum Concentration (Cmax) of MK-0941
Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Time to Reach Cmax (Tmax) of MK-0941
Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Concentration of MK-0941 at 24 Hours (C24hr)
Up to 72 hours after study drug administration
Plasma Pharmacokinetic Parameter: Apparent Terminal Elimination Half-life (t1/2) of MK-0941
Up to 72 hours after study drug administration
- +1 more secondary outcomes
Study Arms (6)
Placebo/MK-0941 20mg
EXPERIMENTALParticipants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
MK-0941 5mg/Placebo
EXPERIMENTALParticipants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.
MK-0941 5mg/MK-0941 20mg
EXPERIMENTALParticipants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
Placebo/MK-0941 40mg
EXPERIMENTALParticipants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
MK-0941 10mg/Placebo
EXPERIMENTALParticipants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.
MK-0941 10mg/MK-0941 40mg
EXPERIMENTALParticipants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
Interventions
Placebo tablets before every meal (q.a.c) Treatment period is 5 days.
MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.
Eligibility Criteria
You may qualify if:
- Japanese Male or Female between 20 to 65 years of age
- Diagnosis of Type 2 Diabetes
- Patient being treated by diet and exercise alone
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2008
First Posted
September 17, 2008
Study Start
September 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
March 12, 2015
Results First Posted
October 3, 2012
Record last verified: 2015-02