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

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: Type 2 Diabetes
• Intervention / Treatment: Drug: MK-0941; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

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	Drug: MK-0941; A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period; Drug: Comparator: Placebo; 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	Drug: MK-0941; A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period; Drug: Comparator: Placebo; 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	Drug: MK-0941; A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period; Drug: Comparator: Placebo; 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	Drug: MK-0941; A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period; Drug: Comparator: Placebo; 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		Up to 30 days after the last dose of study drug
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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

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)