Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

December 11, 2020 updated by: Novartis Pharmaceuticals
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3118

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
      • Nurnberg, Germany
        • Investigative Centers
  • 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 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • On a stable dose of metformin as defined by the protocol
  • Body mass index (BMI) in the range 22-45
  • Blood glucose criteria must be met

Exclusion Criteria:

  • Pregnancy or lactation
  • Type 1 diabetes
  • Evidence of significant diabetic complications
  • Evidence of serious cardiovascular complications
  • Laboratory value abnormalities as defined by the protocol
  • Other protocol-defined 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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Glimepiride
Drug: Metformin
Drug: glimepiride
Drug: Vildagliptin matching placebo
Experimental: Vildagliptin
Drug: Metformin
Drug: vildagliptin
Other Names:
  • LAF237, Galvus
Drug: Glimepiride matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to HbA1c >8%
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in HbA1c at 5 years
Time Frame: 2 years (amended)
2 years (amended)
Adverse event profile after 5 years of treatment
Time Frame: 2 years (amended)
2 years (amended)
Coefficient of failure for HbA1c from week 24 to 5 years
Time Frame: 2 years (amended)
2 years (amended)
Change from baseline in fasting plasma glucose at 5 years
Time Frame: 2 years (amended)
2 years (amended)
Change from baseline in body weight at 5 years
Time Frame: 2 years (amended)
2 years (amended)

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.

Helpful Links

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

March 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 20, 2008

Study Registration Dates

First Submitted

March 22, 2005

First Submitted That Met QC Criteria

March 22, 2005

First Posted (Estimate)

March 23, 2005

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLAF237A2308

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe