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A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

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: NCT00411554
Recruitment Status : Completed
First Posted : December 14, 2006
Results First Posted : September 25, 2009
Last Update Posted : February 5, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Drug: sitagliptin phosphate Drug: Comparator: voglibose Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 319 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sitagliptin (MK0431) Phase III Double-blind Comparative Study - Type 2 Diabetes Mellitus -
Study Start Date : January 2007
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Sitagliptin 50 mg QD
sitagliptin 50 mg orally once daily (QD=once daily)
Drug: sitagliptin phosphate
sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks
Other Name: MK0431
Active Comparator: Voglibose 0.2 mg TID
voglibose 0.2 mg orally three times daily (TID= three times daily)
Drug: Comparator: voglibose
voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks
Other Name: voglibose


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline and Week 12 ]
    HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: Baseline and Week 12 ]
    Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.

  2. Change From Baseline in 2 Hour Postprandial Glucose at Week 12 [ Time Frame: Baseline and Week 12 ]
    Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients have type 2 diabetes mellitus on diet/exercise therapy

Exclusion Criteria:

  • Patients have type 1 diabetes mellitus
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): NCT00411554


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00411554     History of Changes
Other Study ID Numbers: 0431-054
2006_051
First Posted: December 14, 2006    Key Record Dates
Results First Posted: September 25, 2009
Last Update Posted: February 5, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Voglibose
Sitagliptin Phosphate
Inositol
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
Glycoside Hydrolase Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances