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Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00541775
First received: October 5, 2007
Last updated: December 17, 2010
Last verified: December 2010
History of Changes
  Purpose

The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Sitagliptin
Drug: Comparator: Rosiglitazone
Drug: Comparator: Placebo
Drug: Comparator: Metformin
 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, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Hemoglobin A1C (A1C) at Week 18 [ Time Frame: Baseline and 18 Weeks ] [ Designated as safety issue: No ]

    A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.

    The study hypothesis comparison was between sitagliptin versus placebo.



Secondary Outcome Measures:
  • Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and 18 Weeks ] [ Designated as safety issue: No ]
    The change from baseline is the Week 18 FPG minus the Week 0 FPG.

  • 2-hour Post-meal Glucose (PMG) at Week 18 [ Time Frame: Baseline and 18 Weeks ] [ Designated as safety issue: No ]
    The change from baseline is the Week 18 PMG minus the Week 0 PMG.


Enrollment: 273
Study Start Date: June 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sitagliptin
sitagliptin 100 mg
 Drug: Sitagliptin
Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.
Other Name: Januvia
Drug: Comparator: Metformin
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.
Active Comparator: Rosiglitazone
rosiglitazone 8 mg
 Drug: Comparator: Rosiglitazone
Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.
Other Name: Avandia
Drug: Comparator: Metformin
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.
Placebo Comparator: Placebo
placebo
 Drug: Comparator: Placebo
placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.
Drug: Comparator: Metformin
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient has Type 2 diabetes
  • Currently taking metformin >1500 mg/day for at least 10 weeks
  • Male or female

Exclusion Criteria:

  • Patient has peripheral edema
  • History of type 1 diabetes
  • Patient required insulin within prior 8 weeks
  • Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
  • Participating in a weight loss program
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541775

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: NCT00541775     History of Changes
Other Study ID Numbers: MK-0431-801, 2007_623
Study First Received: October 5, 2007
Results First Received: May 17, 2010
Last Updated: December 17, 2010
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rosiglitazone
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 23, 2013