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

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ClinicalTrials.gov Identifier: NCT00758069
Recruitment Status : Completed
First Posted : September 23, 2008
Results First Posted : September 25, 2009
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Non-Insulin-Dependent Drug: sitagliptin phosphate Drug: Comparator: Placebo Drug: Comparator: Sitagliptin Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects
Actual Study Start Date : July 3, 2005
Actual Primary Completion Date : February 13, 2006
Actual Study Completion Date : February 13, 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change From Baseline in 24-hour Weighted Mean Plasma Glucose [ Time Frame: Baseline and Week 4 ]
    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 :
  1. Change From Baseline in Plasma Glucose [ Time Frame: Baseline and Week 4 ]
    Change from baseline at Week 4 is defined as fasting plasma glucose at Week 4 minus fasting plasma glucose at Week 0.



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Ages Eligible for Study:   20 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT00758069


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

Additional Information:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00758069     History of Changes
Other Study ID Numbers: 0431-045
MK0431-045
2008_026
First Posted: September 23, 2008    Key Record Dates
Results First Posted: September 25, 2009
Last Update Posted: May 5, 2017
Last Verified: March 2017

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