Single Doses of MK-0941 in Type 2 Diabetics (MK-0941-027 AM1)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01106287
First received: April 16, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes
Drug: MK-0941
Drug: Comparator: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Higher Single Doses of MK-0941 in Type 2 Diabetics

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    Only treatment-emergent adverse events were examined for this outcome measure.


Enrollment: 13
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: MK-0941
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
Other Name: MK-0941
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
Other Name: MK-0941
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
Other Name: MK-0941
Drug: Comparator: Placebo
a single oral placebo will be administered in the designated period (Periods 1-5)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106287

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01106287     History of Changes
Other Study ID Numbers: 0941-027, 2010_526, MK-0941-027
Study First Received: April 16, 2010
Results First Received: July 3, 2012
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014