Dose Range Finding Study of MK0941 in Patients With Type 2 Diabetes on Insulin


Tracking Information

Start Date  ICMJEOctober 2008
Estimated Primary Completion DateJanuary 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 3, 2008)		HbA1c reduction compared to placebo when MK0941 is added to basal insulin [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00767000 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: July 20, 2009)
  • Effect on 2-hour post meal glucose level compared to placebo when MK0941 is added to basal insulin [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
  • Effect on fasting plasma glucose level when compared to placebo when MK0941 is added to basal insulin [ Time Frame: 14 Weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: October 3, 2008)		Effect on 2-hour post meal glucose level compared to placebo when MK0941 is added to basal insulin [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJEDose Range Finding Study of MK0941 in Patients With Type 2 Diabetes on Insulin
Official Title  ICMJEA Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Range Finding Clinical Trial of MK0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin
Brief Summary

The purpose of this study is to test the effect of MK0941 as add-on therapy for patients taking insulin for Type 2 Diabetes.

Detailed Description

Detailed Description: This study is a 54-week randomized, double-blind base study with an optional 104-week extension study (MK0941-007-10). Patients who complete the 54-week base study will be eligible to enter the extension study and will remain in the treatment group to which they were assigned in the base study

Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEDiabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Comparator: MK0941
    Arm 1: MK0941 10 mg tablets TID. Arm 2: MK0941 20 mg tablets TID Arm 3: MK0941 30 mg tablets TID Arm 4: MK0941 40 mg tablets TID.
  • Drug: Comparator: Placebo
    Placebo to MK0941
  • Biological: Comparator: Lantus
    Lantus injection once daily
Study Arms / Comparison Groups
  • 1: Experimental
    MK0941
    Interventions:
    • Drug: Comparator: MK0941
    • Biological: Comparator: Lantus
  • 2: Experimental
    MK0941
    Interventions:
    • Drug: Comparator: MK0941
    • Biological: Comparator: Lantus
  • 3: Experimental
    MK0941
    Interventions:
    • Drug: Comparator: MK0941
    • Biological: Comparator: Lantus
  • 4: Experimental
    MK0941
    Interventions:
    • Drug: Comparator: MK0941
    • Biological: Comparator: Lantus
  • 5: Placebo Comparator
    Placebo
    Interventions:
    • Drug: Comparator: Placebo
    • Biological: Comparator: Lantus

Recruitment Information

Estimated Enrollment  ICMJE950
Estimated Completion DateJune 2013
Estimated Primary Completion DateJanuary 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Patient is 21 to 70 years old and currently on a stable dose of insulin for Type 2 Diabetes

Extension Study Inclusion Criteria:

  • Patient completed the base study either on double-blind study medication or as part of the post-treatment follow up population

Exclusion Criteria:

  • Patient has any history of Type 1 Diabetes
  • Patient is on a weight loss program and is not in the maintenance phase, or patient is taking a weight loss medication (e.g., orlistat, sibutramine, rimonabant) within 8 weeks of Visit 1
  • patient has undergone surgery within 30 days prior to Visit 1 or has planned major surgery
GenderBoth
Ages21 Years to 70 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Australia,   Austria,   Brazil,   Colombia,   Costa Rica,   Denmark,   Finland,   France,   Germany,   Israel,   Italy,   Jordan,   Korea, Republic of,   Malaysia,   New Zealand,   Norway,   Peru,   Philippines,   Russian Federation,   Saudi Arabia,   South Africa,   Sweden

Administrative Information

NCT ID  ICMJENCT00767000
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2008_557, MK0941-007
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck