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A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)

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ClinicalTrials.gov Identifier: NCT00127192
Recruitment Status : Completed
First Posted : August 5, 2005
Results First Posted : September 25, 2009
Last Update Posted : June 15, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this trial is to determine the efficacy and safety 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 (unspecified) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Sitagliptin (MK0431) Late Phase II Double-Blind Dose-Response Study - Type 2 Diabetes Mellitus
Study Start Date : July 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Placebo QD 12-week
Drug: Comparator: placebo (unspecified)
placebo QD 12-weeks
Experimental: 2
25 mg QD 12-week
Drug: sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Other Name: MK0431
Experimental: 3
50 mg QD 12-week
Drug: sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Other Name: MK0431
Experimental: 4
100 mg QD 12-week
Drug: sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Other Name: MK0431
Experimental: 5
200 mg QD 12-week
Drug: sitagliptin phosphate
sitagliptin phosphate 25 mg, 50 mg, 100 mg QD, or 200 mg QD 12-weeks.
Other Name: MK0431



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 Glycosylated Albumin at Week 12 [ Time Frame: Baseline and Week 12 ]
    Change from baseline at Week 12 is defined as Week 12 minus Week 0.

  2. 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 Week 12 minus Week 0.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus

Exclusion Criteria:

  • Patients with type 1 diabetes mellitus

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): NCT00127192


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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00127192     History of Changes
Other Study ID Numbers: 0431-044
MK0431-044
2005_037
First Posted: August 5, 2005    Key Record Dates
Results First Posted: September 25, 2009
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