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%)
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.
1 other identifier
interventional
317
5 countries
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedDecember 19, 2020
January 1, 2013
1.7 years
July 31, 2008
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy
24 weeks
Secondary Outcomes (4)
FPG reduction
24 weeks
Safety and tolerability
24 weeks
Body weight change from baseline
24 weeks
Changes in the fasting lipid profile
24 weeks
Study Arms (2)
vildagliptin + metformin
EXPERIMENTALmetformin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- History of T2DM treated with Metformin
You may not qualify if:
- FPG \>= 260 mg/dL (14.4mmol/L)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (63)
Unknown Facility
Pine Bluff, Arkansas, 71603, United States
Unknown Facility
Long Beach, California, 90806, United States
Unknown Facility
Denver, Colorado, 80209, United States
Unknown Facility
Bangor, Maine, 04401, United States
Unknown Facility
Billings, Montana, 59102, United States
Novartis Investigative Site
New Brunswick, New Jersey, 08903, United States
Unknown Facility
Trenton, New Jersey, 08611, United States
Unknown Facility
Wilmington, North Carolina, 28409, United States
Unknown Facility
Oklahoma City, Oklahoma, 73104, United States
Unknown Facility
Uniontown, Pennsylvania, United States
Unknown Facility
Taylors, South Carolina, 29687, United States
Unknown Facility
Houston, Texas, 77023, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
Houston, Texas, 77081, United States
Unknown Facility
Norfolk, Virginia, 23510, United States
Unknown Facility
Wenatchee, Washington, 98801, United States
Cabinet d'Endocrinologie-Maladies Métaboliques
Annecy, 74000, France
Service Endocrinologic & Metabolisme
Paris, 75013, France
Polycliniques des minguettes
Vénissieux, 69200, France
Hausärztliche Praxis
Aschaffenburg, 63739, Germany
Klinische Forschung Berlin Mitte GmbH
Berlin, 10117, Germany
AVK
Berlin, 12157, Germany
Gemeinschaftspraxis
Celle, 29221, Germany
Malteser KM
Duisburg, 42259, Germany
Untertrintroper Hausarztzentrum
Essen, 45359, Germany
Unknown Facility
Gefrees, 95482, Germany
Diabeteszentrum Billstedt/Horn
Hamburg, 22119, Germany
Diabetologische Schwerpunktpraxis
Hamburg, 22119, Germany
St. Elisabeth Krankenhaus Leipzig
Leipzig, 04229, Germany
Diabetes-Schwerpunktpraxis Studienambulanz
Leipzig, 04257, Germany
Institut für Diabetes-forschung Münster
Münster, 48145, Germany
Praxis Dr. Alawi
Saarlouis, 66740, Germany
DDT
Siegen, 57072, Germany
Diabetologische Schwerpunktpraxis
Sinsheim, 74889, Germany
Praxis
Wangen, 88239, Germany
Europ-Med Orvosi Szolgaltato Kft
Budaörs, 2040, Hungary
Synexus Magyarorszag
Budapest, 1036, Hungary
Uzsoki Hospital
Budapest, 1145, Hungary
Unknown Facility
Budapest, Hungary
Kenezy Hospital
Debrecen, Hungary
Gyngyosi Korhaz Kft
Gyöngyös, 3200, Hungary
Petz Aladar County
Győr, 9024, Hungary
Selye Janos Korhaz es Rendelointezet
Komárom, 2900, Hungary
DIAPED Kft., MRC
Meggyesalja U., 122, Hungary
Josa Andras Teaching Hospital
Nyíregyháza, 4400, Hungary
Vas Megyei Markuscvszky Lajos Korhaz
Szombathely, 9700, Hungary
Zala County Hospital
Zalaegerszeg, Hungary
NZOZ Specjalistyczny Ośrodek Internistyczno - Diabetologiczny Białystok
Bialystok, 15-435, Poland
Gdanska Poradnia Cukrzycowa
Gdansk, 80-858, Poland
Gabinet Kardiologiczny Mediplus
Gdynia, 81-423, Poland
NZOZ "Esculap" S.C.
Gniewkowo, 88-140, Poland
SZPZOZ Szpital Zachodni im. Jana Pawla II
Grodzisk Mazowiecki, 05-825, Poland
NZOZ Terapia Optima
Katowice, 40-752, Poland
Instytut Cantrum Zdrowia Matki Polki
Lodz, 93-338, Poland
NZOZ Special-Med
Lublin, 20-044, Poland
Szspital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Ponza
Poznan, 60-569, Poland
Lecznica Prosen-SMO NZOZ
Warsaw, 01-231, Poland
Centrum Leczenia Chorob Cywilizacyjnych
Warsaw, 02-777, Poland
NZCZ Regionalna Poradnia Diabetologiczna
Wroclaw, 50-127, Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1
Wroclaw, 50-367, Poland
Samodzielny Publiczny Szpital Kliniczny NR 1 im. Prof. Stanislawa Szysko SAM
Zabrze, 41-800, Poland
Poradnia Diabetologiczna, Zespol Opieki Zdrowotnej w Leczycy
Łęczyca, 99-100, Poland
Zespół Opieki Zdrowotnej w Łęczycy, Poradnia Diabetologiczna Łeczyca
Łęczyca, 99-100, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 5, 2008
Study Start
June 1, 2008
Primary Completion
February 1, 2010
Last Updated
December 19, 2020
Record last verified: 2013-01