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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127192
First Posted: August 5, 2005
Last Update Posted: June 15, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with type 2 diabetes mellitus.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: sitagliptin phosphate Drug: Comparator: placebo (unspecified) Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.


Enrollment: 363
Study Start Date: July 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


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
  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): NCT00127192


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: NCT00127192     History of Changes
Other Study ID Numbers: 0431-044
MK0431-044
2005_037
First Submitted: August 3, 2005
First Posted: August 5, 2005
Results First Submitted: August 18, 2009
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