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

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.

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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