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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00541775
First received: October 5, 2007
Last updated: December 17, 2010
Last verified: December 2010
  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:


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

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
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: NCT00541775

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

Additional Information:
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: Federal Agency for Medicines and Health Products, FAMHP

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 July 23, 2014