- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01106287
Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)
February 3, 2016 updated by: Merck Sharp & Dohme LLC
A Study of Higher Single Doses of MK-0941 in Type 2 Diabetics
This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control
- Diagnosis of Type 2 Diabetes and is either being treated with diet and exercise alone or with a single or combination oral anti-hyperglycemic agent
- No treatment with three of more anti-hyperglycemic agents or any treatment regimen that includes insulin
- In good health (except for Type 2 Diabetes)
- Willingness to follow a specific diet throughout the study (consisting of 50% carbohydrates, 20%protein and 30% fat)
- Nonsmoker
Exclusion Criteria:
- History of stroke, chronic seizure or major neurological disorder
- History of cancer
- History of Type 1 Diabetes
- Recent history of eye infection
- Glaucoma or blindness
- Eye surgery (by incision or laser) within the past three months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment Sequence 1
Period 1: Placebo - Period 2: 80 mg - Period 3: 100 mg - Period 4: Placebo - Period 5: 140 mg
|
A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period
a single oral placebo will be administered in the designated period (Periods 1-5)
|
EXPERIMENTAL: Treatment Sequence 2
Period 1: 60 mg - Period 2: 80 mg - Period 3: 100 mg - Period 4: 120 mg - Period 5: Placebo
|
A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period
a single oral placebo will be administered in the designated period (Periods 1-5)
|
EXPERIMENTAL: Treatment Sequence 3
Period 1: 60 mg - Period 2: Placebo - Period 3: 100 mg - Period 4: 120 mg - Period 5: 140 mg
|
A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period
a single oral placebo will be administered in the designated period (Periods 1-5)
|
EXPERIMENTAL: Treatment Sequence 4
Period 1: 60 mg - Period 2: 80 mg - Period 3: Placebo - Period 4: 120 mg - Period 5: 140 mg
|
A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period
a single oral placebo will be administered in the designated period (Periods 1-5)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Experienced One or More Adverse Events During the Study
Time Frame: Up to 30 days after the last dose of study drug
|
Up to 30 days after the last dose of study drug
|
|
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time Frame: Up to 6 weeks after the first dose of study drug
|
Only treatment-emergent adverse events were examined for this outcome measure.
|
Up to 6 weeks after the first dose of study drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (ACTUAL)
January 1, 2010
Study Completion (ACTUAL)
March 1, 2010
Study Registration Dates
First Submitted
April 16, 2010
First Submitted That Met QC Criteria
April 16, 2010
First Posted (ESTIMATE)
April 19, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
February 4, 2016
Last Update Submitted That Met QC Criteria
February 3, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 0941-027
- 2010_526 (OTHER: Merck Telerex ID Number)
- MK-0941-027 (OTHER: protocol number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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