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

Study Description

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Brief Summary:

The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: sitagliptin phosphate (+) metformin hydrochloride; Drug: metformin	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1246 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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)
Actual Study Start Date :	June 19, 2007
Actual Primary Completion Date :	November 3, 2008
Actual Study Completion Date :	April 27, 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; Arm 1: drug	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™
Active Comparator: 2; Arm 2: active comparator	Drug: metformin; metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Number of Patients With A1C < 7.0% at Week 18 [ Time Frame: Week 18 ]
2. 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.

Other Outcome Measures:

1. 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.
2. Number of Patients With A1C < 7.0% at Week 44 [ Time Frame: Week 44 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 78 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

(MedWatch - FDA maintained medical product safety Information) 

(Merck: Patient &amp; Caregiver U.S. Product Web Site) 

Publications of Results:

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.

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00482729 History of Changes
Other Study ID Numbers:	0431A-079; MK0431A-079; 2007_548
First Posted:	June 5, 2007
Results First Posted:	March 15, 2010
Last Update Posted:	June 9, 2017
Last Verified:	May 2017
Individual Participant Data (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

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Metformin; Sitagliptin Phosphate; Hypoglycemic Agents	Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action