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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00127192
First received: August 3, 2005
Last updated: June 10, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus

Exclusion Criteria:

  • Patients with type 1 diabetes mellitus
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 3, 2005
Results First Received: August 18, 2009
Last Updated: June 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014