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MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)

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ClinicalTrials.gov Identifier: NCT00289848
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : April 2, 2010
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: sitagliptin phosphate Drug: Comparator: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Study Start Date : March 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
sitagliptin 100 mg
 Drug: sitagliptin phosphate
Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.
Other Name: Januvia
Placebo Comparator: 2
placebo
 Drug: Comparator: placebo
placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 [ Time Frame: Baseline and Week 18 ]
    A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and Week 18 ]
    Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.

  2. Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 [ Time Frame: Baseline and Week 18 ]
    Change from baseline at Week 18 is defined as Week 18 minus Week 0.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL

Exclusion Criteria :

  • Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00289848


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  This link exits the ClinicalTrials.gov site
Merck: Patient &amp; Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00289848     History of Changes
Other Study ID Numbers: 0431-040
MK0431-040
2005_094
First Posted: February 10, 2006    Key Record Dates
Results First Posted: April 2, 2010
Last Update Posted: June 15, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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