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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00482729

First received: May 31, 2007

Last updated: May 11, 2017

Last verified: May 2017

History of Changes

Tracking Information

First Received Date ^ICMJE

May 31, 2007

Last Updated Date

May 11, 2017

Actual Start Date ^ICMJE

June 19, 2007

Primary Completion Date

November 3, 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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

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 *

* 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

Enrollment ^ICMJE

1246

Completion Date

April 27, 2009

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, Senior)

Accepts Healthy Volunteers

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

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