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
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: 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 August 21, 2014