Clinical trial NCT00728351: 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%)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes, vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-05
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
timeFrame: 24 weeks
Secondary outcomes:
measure: FPG reduction
timeFrame: 24 weeks
measure: Safety and tolerability
timeFrame: 24 weeks
measure: Body weight change from baseline
timeFrame: 24 weeks
measure: Changes in the fasting lipid profile
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Pine Bluff
country: United States
state: Arkansas
city: Long Beach
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Bangor
country: United States
state: Maine
city: Billings
country: United States
state: Montana
city: New Brunswick
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Trenton
country: United States
state: New Jersey
city: Wilmington
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Uniontown
country: United States
state: Pennsylvania
city: Taylors
country: United States
state: South Carolina
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Wenatchee
country: United States
state: Washington
city: Annecy
country: France
facility: Cabinet d'Endocrinologie-Maladies Métaboliques
city: Paris
country: France
facility: Service Endocrinologic & Metabolisme
city: Venissieux
country: France
facility: Polycliniques des minguettes
city: Aschaffenburg
country: Germany
facility: Hausärztliche Praxis
city: Berlin
country: Germany
facility: Klinische Forschung Berlin Mitte GmbH
city: Berlin
country: Germany
facility: AVK
city: Celle
country: Germany
facility: Gemeinschaftspraxis
city: Duisburg
country: Germany
facility: Malteser KM
city: Essen
country: Germany
facility: Untertrintroper Hausarztzentrum
city: Gefrees
country: Germany
city: Hamburg
country: Germany
facility: Diabeteszentrum Billstedt/Horn
city: Hamburg
country: Germany
facility: Diabetologische Schwerpunktpraxis
city: Leipzig
country: Germany
facility: St. Elisabeth Krankenhaus Leipzig
city: Leipzig
country: Germany
facility: Diabetes-Schwerpunktpraxis Studienambulanz
city: Münster
country: Germany
facility: Institut für Diabetes-forschung Münster
city: Saarlouis
country: Germany
facility: Praxis Dr. Alawi
city: Siegen
country: Germany
facility: DDT
city: Sinsheim
country: Germany
facility: Diabetologische Schwerpunktpraxis
city: Wangen
country: Germany
facility: Praxis
city: Budapest
country: Hungary
facility: Synexus Magyarorszag
city: Budapest
country: Hungary
facility: Uzsoki Hospital
city: Budapest
country: Hungary
city: Budaörs
country: Hungary
facility: Europ-Med Orvosi Szolgaltato Kft
city: Debrecen
country: Hungary
facility: Kenezy Hospital
city: Gyongyos
country: Hungary
facility: Gyngyosi Korhaz Kft
city: Györ
country: Hungary
facility: Petz Aladar County
city: Komarom
country: Hungary
facility: Selye Janos Korhaz es Rendelointezet
city: Meggyesalja U.
country: Hungary
facility: DIAPED Kft., MRC
city: Nyiregyhaza
country: Hungary
facility: Josa Andras Teaching Hospital
city: Szombathely
country: Hungary
facility: Vas Megyei Markuscvszky Lajos Korhaz
city: Zalaegerszeg
country: Hungary
facility: Zala County Hospital
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok
city: Gdansk
country: Poland
facility: Gdanska Poradnia Cukrzycowa
city: Gdynia
country: Poland
facility: Gabinet Kardiologiczny Mediplus
city: Gniewkowo
country: Poland
facility: NZOZ "Esculap" S.C.
city: Grodzisk Mazowiecki
country: Poland
facility: SZPZOZ Szpital Zachodni im. Jana Pawla II
city: Katowice
country: Poland
facility: NZOZ Terapia Optima
city: Leczyca
country: Poland
facility: Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy
city: Leczyca
country: Poland
facility: Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca
city: Lodz
country: Poland
facility: Instytut Cantrum Zdrowia Matki Polki
city: Lublin
country: Poland
facility: NZOZ Special-Med
city: Poznan
country: Poland
facility: Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza
city: Warszawa
country: Poland
facility: Lecznica Prosen-SMO NZOZ
city: Warszawa
country: Poland
facility: Centrum Leczenia Chorob Cywilizacyjnych
city: Wroclaw
country: Poland
facility: NZCZ Regionalna Poradnia Diabetologiczna
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny Nr 1
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: