Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027)

Type 2 Diabetes Clinical Trial

Official title:

A Study of Higher Single Doses of MK-0941 in Type 2 Diabetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106287
• Other study ID #: 0941-027
• Secondary ID: 2010_526MK-0941-
• Status: Completed
• Phase: Phase 1
• First received: April 16, 2010
• Last updated: February 3, 2016
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: February 2016
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and tolerability of single doses of MK-0941 based on assessment of clinical and laboratory adverse experiences

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Drug:
• MK-0941
A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period
• Comparator: Placebo
a single oral placebo will be administered in the designated period (Periods 1-5)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced One or More Adverse Events During the Study		Up to 30 days after the last dose of study drug	Yes
Primary	Number of Participants Who Discontinued Study Drug Due to an Adverse Event	Only treatment-emergent adverse events were examined for this outcome measure.	Up to 6 weeks after the first dose of study drug	Yes