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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%)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00728351
First received: July 31, 2008
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: vildagliptin + metformin
Drug: metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FPG reduction [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Body weight change from baseline [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Changes in the fasting lipid profile [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 317
Study Start Date: June 2008
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vildagliptin + metformin Drug: vildagliptin + metformin
Active Comparator: metformin Drug: metformin
1000 bid metformin

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728351

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

Additional Information:
No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00728351     History of Changes
Other Study ID Numbers: CLMF237A2309
Study First Received: July 31, 2008
Last Updated: January 2, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration

Keywords provided by Novartis:
Type 2 diabetes, vildagliptin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Vildagliptin
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014