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

• ClinicalTrials.gov Identifier: NCT00482729
• Recruitment Status: Completed
• First Posted: June 5, 2007
• Results First Posted: March 15, 2010
• Last Update Posted: June 9, 2017
• Sponsor: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: May 31, 2007
• First Posted Date: 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: June 19, 2007
• Actual Primary Completion Date: November 3, 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided

Current Other Pre-specified Outcome Measures (submitted: March 19, 2010)

• 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 Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Mellitus

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 2, 2010): 1246
• Original Enrollment: 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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT00482729
• Other Study ID Numbers: 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: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: May 2017