Efficacy of Vildagliptin 100 MG as Compared to Placebo as Add-on to Metformin in Patients With Type 2 Diabetes

November 16, 2016 updated by: Novartis Pharmaceuticals

A Multicenter, Double-blind, Randomized, Parallel-Group Study to Compare the Effect of 24 Weeks Treatment With Vildagliptin 100 MG QD to Placebo as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy

Vildagliptin is an oral anti-diabetic agent. This is a 24-week study to assess the efficacy on HbA1c of 100 mg vildagliptin once daily as compared to placebo as add-on to metformin in patients with type 2 diabetes inadequately controlled with metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

370

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

  • Germany
      • Investigative Centers, Germany
        • Novartis Investigative Site
  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • 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

18 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients on metformin for at least three months and on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1
  • Body mass index in the range 22-40
  • Blood glucose criteria must be met

Exclusion Criteria:

  • Pregnancy or lactation
  • History of type 1 diabetes
  • Evidence of significant diabetic complications

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
Experimental: vildagliptin am
Drug: Vildagliptin AM
Experimental: vildagliptin pm
Drug: vildagliptin pm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c at 24 weeks
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in fasting plasma glucose at 24 weeks
Time Frame: 24 weeks
24 weeks
Safety of vildagliptin in combination with metformin during 24 weeks of treatment
Time Frame: 24 weeks
24 weeks
Patients with endpoint HbA1c < 7% after 24 weeks
Time Frame: 24 weeks
24 weeks
Patients with reduction in HbA1c greater than or equal to 0.7% after 24 weeks
Time Frame: 24 weeks
24 weeks
Change from baseline in body weight at 24 weeks
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

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

May 1, 2006

Primary Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

July 11, 2006

First Submitted That Met QC Criteria

July 11, 2006

First Posted (Estimate)

July 13, 2006

Study Record Updates

Last Update Posted (Estimate)

November 18, 2016

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A23103

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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