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Completed

NCT Number: NCT01106287

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

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

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-0941

Drug

A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period

Comparator: placebo

Drug

a single oral placebo will be administered in the designated period (Periods 1-5)

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 19, 2010
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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