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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
ClinicalTrials.gov Identifier:
NCT01106287
First received: April 16, 2010
Last updated: November 15, 2012
Last verified: November 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
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: November 15, 2012
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 May 19, 2013