Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

December 11, 2020 updated by: Novartis Pharmaceuticals

A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

317

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

  • France
      • Annecy, France, 74000
        • Cabinet d'Endocrinologie-Maladies Métaboliques
      • Paris, France, 75013
        • Service Endocrinologic & Metabolisme
      • Venissieux, France, 69200
        • Polycliniques des minguettes
  • Germany
      • Aschaffenburg, Germany, 63739
        • Hausärztliche Praxis
      • Berlin, Germany, 10117
        • Klinische Forschung Berlin Mitte GmbH
      • Berlin, Germany, 12157
        • AVK
      • Celle, Germany, 29221
        • Gemeinschaftspraxis
      • Duisburg, Germany, 42259
        • Malteser KM
      • Essen, Germany, 45359
        • Untertrintroper Hausarztzentrum
      • Gefrees, Germany, 95482
      • Hamburg, Germany, 22119
        • Diabeteszentrum Billstedt/Horn
      • Hamburg, Germany, 22119
        • Diabetologische Schwerpunktpraxis
      • Leipzig, Germany, 04229
        • St. Elisabeth Krankenhaus Leipzig
      • Leipzig, Germany, 04257
        • Diabetes-Schwerpunktpraxis Studienambulanz
      • Münster, Germany, 48145
        • Institut für Diabetes-forschung Münster
      • Saarlouis, Germany, 66740
        • Praxis Dr. Alawi
      • Siegen, Germany, 57072
        • DDT
      • Sinsheim, Germany, 74889
        • Diabetologische Schwerpunktpraxis
      • Wangen, Germany, 88239
        • Praxis
  • Hungary
      • Budapest, Hungary
      • Budapest, Hungary, 1145
        • Uzsoki Hospital
      • Budapest, Hungary, 1036
        • Synexus Magyarorszag
      • Budaörs, Hungary, 2040
        • Europ-Med Orvosi Szolgaltato Kft
      • Debrecen, Hungary
        • Kenézy Hospital
      • Gyongyos, Hungary, 3200
        • Gyngyosi Korhaz Kft
      • Györ, Hungary, 9024
        • Petz Aladar County
      • Komarom, Hungary, 2900
        • Selye Janos Korhaz es Rendelointezet
      • Meggyesalja U., Hungary, 122
        • DIAPED Kft., MRC
      • Nyiregyhaza, Hungary, 4400
        • Josa Andras Teaching Hospital
      • Szombathely, Hungary, 9700
        • Vas Megyei Markuscvszky Lajos Korhaz
      • Zalaegerszeg, Hungary
        • Zala County Hospital
  • Poland
      • Bialystok, Poland, 15-435
        • NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok
      • Gdansk, Poland, 80-858
        • Gdanska Poradnia Cukrzycowa
      • Gdynia, Poland, 81-423
        • Gabinet Kardiologiczny Mediplus
      • Gniewkowo, Poland, 88-140
        • NZOZ "Esculap" S.C.
      • Grodzisk Mazowiecki, Poland, 05-825
        • SZPZOZ Szpital Zachodni im. Jana Pawla II
      • Katowice, Poland, 40-752
        • NZOZ Terapia Optima
      • Leczyca, Poland, 99-100
        • Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy
      • Leczyca, Poland, 99-100
        • Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca
      • Lodz, Poland, 93-338
        • Instytut Cantrum Zdrowia Matki Polki
      • Lublin, Poland, 20-044
        • NZOZ Special-Med
      • Poznan, Poland, 60-569
        • Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza
      • Warszawa, Poland, 02-777
        • Centrum Leczenia Chorób Cywilizacyjnych
      • Warszawa, Poland, 01-231
        • Lecznica Prosen-SMO NZOZ
      • Wroclaw, Poland, 50-367
        • Samodzielny Publiczny Szpital Kliniczny nr 1
      • Wroclaw, Poland, 50-127
        • NZCZ Regionalna Poradnia Diabetologiczna
      • Zabrze, Poland, 41-800
        • Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM
  • United States
    • Arkansas
      • Pine Bluff, Arkansas, United States, 71603
    • California
      • Long Beach, California, United States, 90806
    • Colorado
      • Denver, Colorado, United States, 80209
    • Maine
      • Bangor, Maine, United States, 04401
    • Montana
      • Billings, Montana, United States, 59102
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Novartis Investigative Site
      • Trenton, New Jersey, United States, 08611
    • North Carolina
      • Wilmington, North Carolina, United States, 28409
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Uniontown, Pennsylvania, United States
    • South Carolina
      • Taylors, South Carolina, United States, 29687
    • Texas
      • Houston, Texas, United States, 77074
      • Houston, Texas, United States, 77023
      • Houston, Texas, United States, 77081
    • Virginia
      • Norfolk, Virginia, United States, 23510
    • Washington
      • Wenatchee, Washington, United States, 98801

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:

  • History of T2DM treated with Metformin

Exclusion Criteria:

  • FPG >= 260 mg/dL (14.4mmol/L)

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vildagliptin + metformin
Drug: vildagliptin + metformin
Active Comparator: metformin
Drug: metformin
1000 bid metformin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability
Time Frame: 24 weeks
24 weeks
FPG reduction
Time Frame: 24 weeks
24 weeks
Body weight change from baseline
Time Frame: 24 weeks
24 weeks
Changes in the fasting lipid profile
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.

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

June 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimate)

August 5, 2008

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLMF237A2309

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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