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Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00758069
First received: September 22, 2008
Last updated: April 21, 2010
Last verified: April 2010
History of Changes
  Purpose

A 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: Placebo
Drug: Comparator: Sitagliptin
 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: Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in 24-hour Weighted Mean Plasma Glucose [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.


Secondary Outcome Measures:
  • Change From Baseline in Plasma Glucose [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.


Enrollment: 80
Study Start Date: July 2005
Study Completion Date: October 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Drug: Comparator: Placebo
Placebo tablet, QD, taken orally for 4 weeks
Experimental: 2
Sitagliptin 100 mg
 Drug: sitagliptin phosphate
100 mg once daily (QD), taken orally for 4 weeks
Other Name: MK0431
Experimental: 3
Sitagliptin 50 mg
 Drug: Comparator: Sitagliptin
50 mg twice daily (BID), taken orally for 4 weeks
Other Name: MK0431

  Eligibility

Ages Eligible for Study:   20 Years to 69 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758069

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00758069     History of Changes
Other Study ID Numbers: 2008_026, MK0431-045
Study First Received: September 22, 2008
Results First Received: August 17, 2009
Last Updated: April 21, 2010
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
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013