MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sitagliptin phosphate (+) metformin hydrochloride
metformin
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Patient has type 2 diabetes mellitus
- Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
- Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
- Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
- Patient is a male, or a female who is unlikely to conceive
Exclusion Criteria:
- Patient has type 1 diabetes mellitus or history of ketoacidosis
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Arm 1: drug
Arm 2: active comparator
Outcomes
Primary Outcome Measures
Change From Baseline in Hemoglobin A1c (A1C) at Week 18
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Secondary Outcome Measures
Number of Patients With A1C < 7.0% at Week 18
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00482729
Brief Title
MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
Official Title
A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 19, 2007 (Actual)
Primary Completion Date
November 3, 2008 (Actual)
Study Completion Date
April 27, 2009 (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
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.
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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1246 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Arm 1: drug
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arm 2: active comparator
Intervention Type
Drug
Intervention Name(s)
sitagliptin phosphate (+) metformin hydrochloride
Other Intervention Name(s)
MK0431A, Janumet™
Intervention Description
sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
Primary Outcome Measure Information:
Title
Change From Baseline in Hemoglobin A1c (A1C) at Week 18
Description
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Time Frame
Baseline and Week 18
Secondary Outcome Measure Information:
Title
Number of Patients With A1C < 7.0% at Week 18
Time Frame
Week 18
Title
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18
Description
FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.
Time Frame
Baseline and Week 18
Other Pre-specified Outcome Measures:
Title
Change From Baseline in A1C at Week 44
Description
A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.
Time Frame
Baseline and Week 44
Title
Number of Patients With A1C < 7.0% at Week 44
Time Frame
Week 44
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has type 2 diabetes mellitus
Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
Patient is a male, or a female who is unlikely to conceive
Exclusion Criteria:
Patient has type 1 diabetes mellitus or history of ketoacidosis
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
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
21410627
Citation
Reasner C, Olansky L, Seck TL, Williams-Herman DE, Chen M, Terranella L, Johnson-Levonas AO, Kaufman KD, Goldstein BJ. The effect of initial therapy with the fixed-dose combination of sitagliptin and metformin compared with metformin monotherapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2011 Jul;13(7):644-52. doi: 10.1111/j.1463-1326.2011.01390.x.
Results Reference
result
PubMed Identifier
21535346
Citation
Olansky L, Reasner C, Seck TL, Williams-Herman DE, Chen M, Terranella L, Mehta A, Kaufman KD, Goldstein BJ. A treatment strategy implementing combination therapy with sitagliptin and metformin results in superior glycaemic control versus metformin monotherapy due to a low rate of addition of antihyperglycaemic agents. Diabetes Obes Metab. 2011 Sep;13(9):841-9. doi: 10.1111/j.1463-1326.2011.01416.x.
Results Reference
result
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MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
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