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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00411554
First received: December 13, 2006
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Drug: sitagliptin phosphate
Drug: Comparator: voglibose
Phase 3

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) Phase III Double-blind Comparative 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 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 fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.

  • Change From Baseline in 2 Hour Postprandial Glucose at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.


Enrollment: 319
Study Start Date: January 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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: NCT00411554

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00411554     History of Changes
Other Study ID Numbers: 0431-054, 2006_051
Study First Received: December 13, 2006
Results First Received: August 19, 2009
Last Updated: February 21, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on August 28, 2014