Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00758069
First received: September 22, 2008
Last updated: July 7, 2014
Last verified: July 2014
  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:


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

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: February 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
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: NCT00758069

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00758069     History of Changes
Other Study ID Numbers: 0431-045, MK0431-045, 2008_026
Study First Received: September 22, 2008
Results First Received: August 17, 2009
Last Updated: July 7, 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
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 September 15, 2014