Vildagliptin Versus Sitagliptin - Differences in Fasting Plasma Glucose Lowering Efficacy (FPG-VISIT)

February 11, 2013 updated by: Novartis Pharmaceuticals

Cross-over Study to Assess the Difference in Fasting Plasma Glucose (FPG) Between Vildagliptin (Galvus®/Eucreas®) and Sitagliptin (Januvia®/Janumet®) After Two Weeks

This study is designed to assess the potential difference in Fasting Plasma Glucose (FPG) lowering efficacy between the two DPP-4 inhibitors vildagliptin and sitagliptin, both after a two weeks treatment on top of metformin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

187

Phase

  • Phase 4

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
      • Bad Oeynhausen, Germany, 32549
        • Novartis Investigative Site
      • Berlin, Germany, 12347
        • Novartis Investigative Site
      • Berlin, Germany, 13597
        • Novartis Investigative Site
      • Berlin, Germany, 14089
        • Novartis Investigative Site
      • Celle, Germany, 29221
        • Novartis Investigative Site
      • Hannover, Germany, 30167
        • Novartis Investigative Site
      • Hannover, Germany, 30165
        • Novartis Investigative Site
      • Kassel, Germany, 34117
        • Novartis Investigative Site
      • Kirchhain, Germany, 35274
        • Novartis Investigative Site
      • Lehrte, Germany, 31275
        • Novartis Investigative Site
      • Mülheim, Germany, 45468
        • Novartis Investigative Site
      • Oberhausen, Germany, 46049
        • Novartis Investigative Site
      • Osnabrück, Germany, 49080
        • Novartis Investigative Site
      • Potsdam, Germany, 14469
        • Novartis Investigative Site
      • Stuttgart, Germany, 70378
        • Novartis Investigative Site

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

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients with type 2 diabetes 18 to 85 years Metformin monotherapy > 4 weeks HbA1c 6.5 - 9.5%

Exclusion Criteria:

FPG > 270 mg/dl Use of other antidiabetic drugs than metformin major cardiovascular event in the last 6 months (MI, stroke…)

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vildagliptin
Experimental
Drug: Vildagliptin
50mg vildagliptin bid
Active Comparator: Sitagliptin
Active comparator (drug)
Drug: Sitagliptin
100mg sitagliptin po qd

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
demonstrate that the FPG after 14 days of treatment with Vildagliptin is superior to the FPG after 14 days of treatment with Sitagliptin
Time Frame: 14 days
Fasting Plasma Glucose measured on day 14.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the difference in FPG between vildagliptin and sitagliptin in patients with type 2 diabetes mellitus on concomitant treatment with metformin
Time Frame: 14 days
Fasting Plasma Glucose on day 14 analyzed descriptively.
14 days

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Investigators

  • Principal Investigator: Rüdiger Göke, MD, Kirchhain

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

June 1, 2011

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

July 15, 2011

First Submitted That Met QC Criteria

July 19, 2011

First Posted (Estimate)

July 20, 2011

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLMF237ADE02
  • 2011-000518-21 (EudraCT Number)

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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