A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Registration Number
- NCT00901979
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will assess the effect of LCQ when added to metformin.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 693
- HbA1c from 7.0-10.0%, Stable Metformin dose
- CHF Class III-IV, Liver disease
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo metformin - Sitagliptin Sitagliptin - Sitagliptin metformin - LCQ908 Dose 1 metformin - LCQ908 Dose 2 LCQ908A - LCQ908 Dose 2 metformin - LCQ908 Dose 3 LCQ908A - LCQ908 Dose 4 LCQ908A - LCQ908 Dose 1 LCQ908A - LCQ908 Dose 5 LCQ908A - LCQ908 Dose 5 metformin - Placebo Placebo - LCQ908 Dose 3 metformin - LCQ908 Dose 4 metformin -
- Primary Outcome Measures
Name Time Method Effect of LCQ on measures of glucose control 12 weeks
- Secondary Outcome Measures
Name Time Method Changes in body weight and related measures 12 weeks Insulin sensitivity 12 weeks Safety and tolerability 12 weeks
Trial Locations
- Locations (67)
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
John Muir Clinical Research
🇺🇸Concord, California, United States
Dallas Diabetic and Endocrinology Research Center
🇺🇸Dallas, Texas, United States
Radiant Research - North Dallas
🇺🇸Dallas, Texas, United States
Credit Valley Prof Bldg
🇨🇦Mississauga, Ontario, Canada
Southwestern Medical Clinic
🇺🇸Bridgman, Michigan, United States
Michigan State University - Kalamazoo Ctr for Med Studies
🇺🇸Kalamazoo, Michigan, United States
Mississippi Medical Research, LLC
🇺🇸Picayune, Mississippi, United States
Clinique Médicale Millénia Santé
🇨🇦Québec, Quebec, Canada
Accurate Clinical Research
🇺🇸Houston, Texas, United States
Blalock Clinical Research
🇺🇸Houston, Texas, United States
Texas Center for Drug Development, P.A.
🇺🇸Houston, Texas, United States
Research Center Phase I-IV of Florida, Corp.
🇺🇸Miami, Florida, United States
Clinical Research Advantage
🇺🇸Mesa, Arizona, United States
Mesa Family Medical Center/Clinical Research Advantage
🇺🇸Mesa, Arizona, United States
Apex Research of Riverside
🇺🇸Riverside, California, United States
MacNeal Center for Clinical Research
🇺🇸Berwyn, Illinois, United States
Rivergrove Medical Clinic
🇨🇦Winnipeg, Manitoba, Canada
Cotton-O'Neil Clinical Research Center Topeka KS United States
🇺🇸Topeka, Kansas, United States
Health Sciences Centre - Diabetes Research Group
🇨🇦Winnipeg, Manitoba, Canada
Complete Family Care
🇺🇸Northglenn, Colorado, United States
CNRI-San Diego, LLC
🇺🇸San Diego, California, United States
California Research Foundation
🇺🇸San Diego, California, United States
Denver VA Medical Center
🇺🇸Denver, Colorado, United States
Woodland International Reserach Group, LLC
🇺🇸Little Rock, Arkansas, United States
Associated Pharmaceutical Research
🇺🇸Buena Park, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
🇵🇱Olawa, Poland
Diablo Clinical
🇺🇸Walnut Creek, California, United States
Perimeter North Medical Research
🇺🇸Roswell, Georgia, United States
Venture Resource Group
🇺🇸Overland Park, Kansas, United States
Graves Gilbert Clinic Bowling Green KY United States
🇺🇸Bowling Green, Kentucky, United States
Commonwealth Biomedical Research, LLC
🇺🇸Madisonville, Kentucky, United States
Centennial Medical Group
🇺🇸Elkridge, Maryland, United States
International Research Center Towson MD United States
🇺🇸Towson, Maryland, United States
Clarkston Medical Group
🇺🇸Clarkston, Michigan, United States
Fallon Clinic Worcester MA United States
🇺🇸Worcester, Massachusetts, United States
ClinVest Research
🇺🇸Springfield, Missouri, United States
Montana Medical Research
🇺🇸Missoula, Montana, United States
St. John's Clinic - Medical Research
🇺🇸Springfield, Missouri, United States
Meera Dewan, P.C.
🇺🇸Omaha, Nebraska, United States
Libra Clinical Research Associates
🇺🇸Brick, New Jersey, United States
Physicians Research Center
🇺🇸Toms River, New Jersey, United States
*Private Practice* Staten Island
🇺🇸Staten Island, New York, United States
Southwind Medical Specialists Memphis TN United States
🇺🇸Memphis, Tennessee, United States
Medical Frontiers LLC
🇺🇸Carlisle, Ohio, United States
Ettrick Health Center
🇺🇸Ettrick, Virginia, United States
McGuire Veterans Medical Center
🇺🇸Richmond, Virginia, United States
Northwest Clinical Research
🇺🇸Bellevue, Washington, United States
Providence Physicians Group
🇺🇸Monroe, Washington, United States
CHUS - Hopital Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Hopital Maisonneuve-Rosemont
🇨🇦Montreal, Quebec, Canada
Institut de Recherches Cliniques
🇨🇦Montreal, Quebec, Canada
Hamilton Medical Research Group
🇨🇦Sherbrooke, Ontario, Canada
A.O.Polo Universitario Luigi Sacco
🇮🇹Milano, Italy
Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio
🇮🇹Chieti, Italy
Azienda Ospedaliera-Ospedali Riuniti di Bergamo
🇮🇹Bergamo, Italy
Presidio Ospedaliero di Cisanello Università degli Studi
🇮🇹Pisa, Italy
Istituto Scientifico San Raffaele - IRCCS
🇮🇹Milano, Italy
Ospedale S.Giovanni di Dio
🇮🇹Olbia, Italy
Policlinica Dr. Luis Rodriguez Carrasquillo
🇵🇷Carolina, Puerto Rico
Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale
🇮🇹Roma, Italy
Endocrine Lipid Diabetes Research Institute Ponce PR United States
🇵🇷Ponce, Puerto Rico
Miguel Sosa-Padilla, M.D.
🇵🇷San Juan, Puerto Rico
Endwell Family Physician
🇺🇸Endwell, New York, United States
*Private Practice*
🇺🇸Pasadena, California, United States
Radiant Research
🇺🇸Greer, South Carolina, United States