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A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00511667
First Posted: August 6, 2007
Last Update Posted: August 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
A multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: MK0941 Drug: Comparator: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration of MK0941 Before Each Meal (q.a.c.) in Subjects With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Participants With Any Clinical Adverse Experience [ Time Frame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal) ]
  • Participants Discontinued Because of Any Clinical Adverse Experience [ Time Frame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal) ]

Secondary Outcome Measures:
  • Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941 [ Time Frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) ]
  • Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941 [ Time Frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) ]
  • Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941 [ Time Frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) ]
  • Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941 [ Time Frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) ]
  • Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941 [ Time Frame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day) ]

Enrollment: 70
Study Start Date: May 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK0941 Drug: MK0941
MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
Placebo Comparator: Placebo Drug: Comparator: Placebo
Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nonsmoking Male or Female (of non-child bearing potential)
  • Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents
  • Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more

Exclusion Criteria:

  • Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist
  • Subject is on 3 or more oral anti-diabetes medications
  • Subject has a history of type 1 diabetes
  • Subject has a diagnosis of glaucoma or is blind
  • Subject has had trauma to one or both eyes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00511667


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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00511667     History of Changes
Other Study ID Numbers: 0941-005
2007_595
First Submitted: August 2, 2007
First Posted: August 6, 2007
Results First Submitted: April 4, 2012
Results First Posted: June 26, 2012
Last Update Posted: August 24, 2016
Last Verified: August 2016

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