To Assess the Efficacy and Safety of Vildagliptin as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

May 10, 2007 updated by: Novartis

A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With Vildagliptin to Placebo as Add-on Therapy to Sulfonylurea in Patients With Type 2 Diabetes Inadequately Controlled With Sulfonylurea Monotherapy

This study is not being conducted in the United States. Vildagliptin is an oral antidiabetic agent. This 12-week clinical study is designed as a multicenter, randomized, double-blind, parallel-group, placebo-controlled study aimed to evaluate the efficacy and safety of vildagliptin as add-on therapy to a sulfonylurea in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of type 2 diabetes and treated with a stable dose of sulfonylurea
  • Patients on diet and exercise who have not reached target blood glucose levels
  • Outpatients

Exclusion Criteria:

  • Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes
  • Significant cardiovascular complications as defined by the protocol
  • Significant diabetic complications as defined by the protocol

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline to endpoint on HbA1c at 12 weeks

Secondary Outcome Measures

Outcome Measure
Change from baseline to endpoint on fasting plasma glucose at 12 weeks
Change from baseline to endpoint in HOMA B at 12 weeks
Change from baseline to endpoint in HOMA IR at 12 weeks
Change from baseline to endpoint on fasting lipids at 12 weeks
Adverse events profile after 12 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Registration Dates

First Submitted

May 10, 2006

First Submitted That Met QC Criteria

May 10, 2006

First Posted (Estimate)

May 12, 2006

Study Record Updates

Last Update Posted (Estimate)

May 14, 2007

Last Update Submitted That Met QC Criteria

May 10, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A1302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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