Clinical trial NCT00901979: A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-05-14
Enrollment: 693
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the effect of LCQ when added to metformin.


Eligibility criteria: Inclusion Criteria:

* HbA1c from 7.0-10.0%, Stable Metformin dose

Exclusion Criteria:

* CHF Class III-IV, Liver disease

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Effect of LCQ on measures of glucose control
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in body weight and related measures
timeFrame: 12 weeks
measure: Insulin sensitivity
timeFrame: 12 weeks
measure: Safety and tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Clinical Research Advantage
state: Arizona
city: Mesa
country: United States
facility: Mesa Family Medical Center/Clinical Research Advantage
state: Arizona
city: Little Rock
country: United States
facility: Woodland International Reserach Group, LLC
state: Arkansas
city: Buena Park
country: United States
facility: Associated Pharmaceutical Research
state: California
city: Concord
country: United States
facility: John Muir Clinical Research
state: California
city: Pasadena
country: United States
facility: *Private Practice*
state: California
city: Riverside
country: United States
facility: Apex Research of Riverside
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: San Diego
country: United States
facility: CNRI-San Diego, LLC
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical
state: California
city: Denver
country: United States
facility: Denver VA Medical Center
state: Colorado
city: Northglenn
country: United States
facility: Complete Family Care
state: Colorado
city: Miami
country: United States
facility: Research Center Phase I-IV of Florida, Corp.
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute, Inc.
state: Florida
city: Roswell
country: United States
facility: Perimeter North Medical Research
state: Georgia
city: Berwyn
country: United States
facility: MacNeal Center for Clinical Research
state: Illinois
city: Overland Park
country: United States
facility: Venture Resource Group
state: Kansas
city: Topeka
country: United States
facility: Cotton-O'Neil Clinical Research Center Topeka KS United States
state: Kansas
city: Bowling Green
country: United States
facility: Graves Gilbert Clinic Bowling Green KY United States
state: Kentucky
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Towson
country: United States
facility: International Research Center Towson MD United States
state: Maryland
city: Worcester
country: United States
facility: Fallon Clinic Worcester MA United States
state: Massachusetts
city: Bridgman
country: United States
facility: Southwestern Medical Clinic
state: Michigan
city: Clarkston
country: United States
facility: Clarkston Medical Group
state: Michigan
city: Kalamazoo
country: United States
facility: Michigan State University - Kalamazoo Ctr for Med Studies
state: Michigan
city: Picayune
country: United States
facility: Mississippi Medical Research, LLC
state: Mississippi
city: Springfield
country: United States
facility: ClinVest Research
state: Missouri
city: Springfield
country: United States
facility: St. John's Clinic - Medical Research
state: Missouri
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Omaha
country: United States
facility: Meera Dewan, P.C.
state: Nebraska
city: Brick
country: United States
facility: Libra Clinical Research Associates
state: New Jersey
city: Toms River
country: United States
facility: Physicians Research Center
state: New Jersey
city: Endwell
country: United States
facility: Endwell Family Physician
state: New York
city: Staten Island
country: United States
facility: *Private Practice* Staten Island
state: New York
city: Carlisle
country: United States
facility: Medical Frontiers LLC
state: Ohio
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Memphis
country: United States
facility: Southwind Medical Specialists Memphis TN United States
state: Tennessee
city: Dallas
country: United States
facility: Dallas Diabetic and Endocrinology Research Center
state: Texas
city: Dallas
country: United States
facility: Radiant Research - North Dallas
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Houston
country: United States
facility: Blalock Clinical Research
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development, P.A.
state: Texas
city: Ettrick
country: United States
facility: Ettrick Health Center
state: Virginia
city: Richmond
country: United States
facility: McGuire Veterans Medical Center
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research
state: Washington
city: Monroe
country: United States
facility: Providence Physicians Group
state: Washington
city: Winnipeg
country: Canada
facility: Health Sciences Centre - Diabetes Research Group
state: Manitoba
city: Winnipeg
country: Canada
facility: Rivergrove Medical Clinic
state: Manitoba
city: Mississauga
country: Canada
facility: Credit Valley Prof Bldg
state: Ontario
city: Sherbrooke
country: Canada
facility: Hamilton Medical Research Group
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Institut de Recherches Cliniques
state: Quebec
city: Québec
country: Canada
facility: Clinique Médicale Millénia Santé
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont
state: Quebec
city: Bergamo
country: Italy
facility: Azienda Ospedaliera-Ospedali Riuniti di Bergamo
city: Chieti
country: Italy
facility: Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio
city: Milano
country: Italy
facility: A.O.Polo Universitario Luigi Sacco
city: Milano
country: Italy
facility: Istituto Scientifico San Raffaele - IRCCS
city: Olbia
country: Italy
facility: Ospedale S.Giovanni di Dio
city: Pisa
country: Italy
facility: Presidio Ospedaliero di Cisanello Università degli Studi
city: Roma
country: Italy
facility: Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale
city: Olawa
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej
city: Carolina
country: Puerto Rico
facility: Policlinica Dr. Luis Rodriguez Carrasquillo
city: Ponce
country: Puerto Rico
facility: Endocrine Lipid Diabetes Research Institute Ponce PR United States
city: San Juan
country: Puerto Rico
facility: Miguel Sosa-Padilla, M.D.
Study officials:
References: