Back to resultsMK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks
Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria: Patients have type 2 diabetes mellitus On diet/exercise therapy Exclusion Criteria: Patients have type 1 diabetes mellitus
Sites / Locations
Outcomes
Primary Outcome Measures
HbA1c, safety and tolerability
Secondary Outcome Measures
Plasma glucose
Full Information
NCT ID
NCT00371007
First Posted
August 31, 2006
Last Updated
March 31, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00371007
Brief Title
MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)
Official Title
MK0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2004 (Actual)
Primary Completion Date
April 25, 2005 (Actual)
Study Completion Date
April 25, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
A clinical study to determine the safety and efficacy of MK-0431 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
126 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0431, sitagliptin phosphate / Duration of Treatment: 12 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator : placebo (unspecified) / Duration of Treatment: 12 Weeks
Primary Outcome Measure Information:
Title
HbA1c, safety and tolerability
Secondary Outcome Measure Information:
Title
Plasma glucose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients have type 2 diabetes mellitus
On diet/exercise therapy
Exclusion Criteria:
Patients have type 1 diabetes mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17933414
Citation
Nonaka K, Kakikawa T, Sato A, Okuyama K, Fujimoto G, Kato N, Suzuki H, Hirayama Y, Ahmed T, Davies MJ, Stein PP. Efficacy and safety of sitagliptin monotherapy in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008 Feb;79(2):291-8. doi: 10.1016/j.diabres.2007.08.021. Epub 2007 Oct 22.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
MK-0431 Early Phase II Double-blind Study - Type 2 Diabetes Mellitus (0431-043)
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