MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)

Tracking Information
First Submitted Date ICMJE	May 31, 2007
First Posted Date ICMJE	June 5, 2007
Results First Submitted Date	December 9, 2009
Results First Posted Date	March 15, 2010
Last Update Posted Date	June 9, 2017
Actual Study Start Date ICMJE	June 19, 2007
Actual Primary Completion Date	November 3, 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: March 2, 2010)	Change From Baseline in Hemoglobin A1c (A1C) at Week 18 [ Time Frame: Baseline and Week 18 ]; A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00482729 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: March 2, 2010)	Number of Patients With A1C < 7.0% at Week 18 [ Time Frame: Week 18 ]; Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and 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.
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE; (submitted: November 12, 2013)	Change From Baseline in A1C at Week 44 [ Time Frame: Baseline and Week 44 ]A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.; Number of Patients With A1C < 7.0% at Week 44 [ Time Frame: Week 44 ]
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
Official Title ICMJE	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)
Brief Summary	The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Type 2 Diabetes Mellitus
Intervention ICMJE	Drug: sitagliptin phosphate (+) metformin hydrochloride 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. Other Names: MK0431A Janumet™; Drug: metformin metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
Study Arms	Experimental: 1 Arm 1: drug Intervention: Drug: sitagliptin phosphate (+) metformin hydrochloride; Active Comparator: 2 Arm 2: active comparator Intervention: Drug: metformin
Publications *	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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: March 2, 2010)	1246
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	April 27, 2009
Actual Primary Completion Date	November 3, 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 78 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	Puerto Rico, United States
Administrative Information
NCT Number ICMJE	NCT00482729
Other Study ID Numbers ICMJE	0431A-079; MK0431A-079; 2007_548
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: Yes 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
Responsible Party	Merck Sharp & Dohme Corp.
Study Sponsor ICMJE	Merck Sharp & Dohme Corp.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account	Merck Sharp & Dohme Corp.
Verification Date	May 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP