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Sitagliptin Comparative Study in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00449930
First received: March 19, 2007
Last updated: April 20, 2010
Last verified: April 2010
History of Changes
  Purpose

A study to evaluate the efficacy and safety of sitagliptin in comparison to a commonly used medication in patients with type 2 diabetes


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: sitagliptin phosphate
Drug: Comparator: metformin hydrochloride
 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: A Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Metformin in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24 [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
    HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.


Secondary Outcome Measures:
  • Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Diarrhea [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Nausea [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Abdominal Pain [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Number of Patients Who Reported 1 or More Episodes of the Adverse Experience of Vomiting [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Enrollment: 1050
Study Start Date: March 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug
 Drug: sitagliptin phosphate
(1) sitagliptin 100mg tablet once daily (q.d.) for a 24-wk treatment period
Other Name: MK0431
Active Comparator: 2
Active comparator
 Drug: Comparator: metformin hydrochloride
(4) Metformin 500mg tablets once daily (q.d.) for a 24-wk treatment period.

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  • Patient has type 2 diabetes mellitus (T2DM)
  • Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient was on antihyperglycemic therapy (insulin or oral) within the prior 4 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449930

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

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00449930     History of Changes
Other Study ID Numbers: 2006_561, MK0431-049
Study First Received: March 19, 2007
Results First Received: June 23, 2009
Last Updated: April 20, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 19, 2013