A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00511667
First received: August 2, 2007
Last updated: May 22, 2012
Last verified: May 2012
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511667

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: NCT00511667     History of Changes
Other Study ID Numbers: MK-0941-005, 2007_595, MK-0941-005
Study First Received: August 2, 2007
Results First Received: April 4, 2012
Last Updated: May 22, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014