Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00875394

Recruitment Status : Completed

First Posted : April 3, 2009

Results First Posted : April 20, 2011

Last Update Posted : May 30, 2017

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Non-Insulin-Dependent	Drug: sitagliptin phosphate Drug: Comparator: metformin Drug: Comparator: Antidiabetic Standard of Care	Phase 3

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	68 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin
Actual Study Start Date :	February 1, 2007
Actual Primary Completion Date :	June 27, 2008
Actual Study Completion Date :	June 27, 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

Drug Information available for: Metformin Metformin hydrochloride Sitagliptin Sitagliptin phosphate

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 sitagliptin + metformin	Drug: sitagliptin phosphate sitagliptin 100 mg Once a day (QD) for 24 weeks Other Name: sitagliptin Drug: Comparator: metformin metformin 850 mg Twice a day (BID) for 24 weeks Other Name: metformin
Active Comparator: 2 metformin + any other oral antidiabetic drug	Drug: Comparator: metformin metformin 850 mg Twice a day (BID) for 24 weeks Other Name: metformin Drug: Comparator: Antidiabetic Standard of Care Patient can take any oral antidiabetic drug (other than metformin)
Active Comparator: 3 metformin	Drug: Comparator: metformin metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks Other Name: metformin

Outcome Measures

Primary Outcome Measures :

Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24 [ Time Frame: Baseline and 24 weeks ]
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study:	30 Years to 78 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient Has Type 2 Diabetes Mellitus
Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
Patient Is Currently On Metformin Therapy (1500 Mg/Day)
Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
Patient Has An A1c of 6.5 % - 11.0%

Exclusion Criteria:

Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875394

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Layout table for investigator information

Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Layout table for additonal information

Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00875394
Other Study ID Numbers:	0431-189 2009_571
First Posted:	April 3, 2009 Key Record Dates
Results First Posted:	April 20, 2011
Last Update Posted:	May 30, 2017
Last Verified:	April 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:

Layout table for 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

To Top