A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
1 other identifier
interventional
693
5 countries
67
Brief Summary
This study will assess the effect of LCQ when added to metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Apr 2009
67 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
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 13, 2009
CompletedFirst Posted
Study publicly available on registry
May 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedJanuary 9, 2013
January 1, 2013
1.2 years
May 13, 2009
January 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of LCQ on measures of glucose control
12 weeks
Secondary Outcomes (3)
Changes in body weight and related measures
12 weeks
Insulin sensitivity
12 weeks
Safety and tolerability
12 weeks
Study Arms (7)
LCQ908 Dose 1
EXPERIMENTALLCQ908 Dose 2
EXPERIMENTALLCQ908 Dose 3
EXPERIMENTALLCQ908 Dose 4
EXPERIMENTALLCQ908 Dose 5
EXPERIMENTALPlacebo
PLACEBO COMPARATORSitagliptin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- HbA1c from 7.0-10.0%, Stable Metformin dose
You may not qualify if:
- CHF Class III-IV, Liver disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Clinical Research Advantage
Mesa, Arizona, United States
Mesa Family Medical Center/Clinical Research Advantage
Mesa, Arizona, United States
Woodland International Reserach Group, LLC
Little Rock, Arkansas, United States
Associated Pharmaceutical Research
Buena Park, California, United States
John Muir Clinical Research
Concord, California, United States
*Private Practice*
Pasadena, California, United States
Apex Research of Riverside
Riverside, California, United States
California Research Foundation
San Diego, California, United States
CNRI-San Diego, LLC
San Diego, California, United States
Orange County Research Center
Tustin, California, United States
Diablo Clinical
Walnut Creek, California, United States
Denver VA Medical Center
Denver, Colorado, United States
Complete Family Care
Northglenn, Colorado, United States
Research Center Phase I-IV of Florida, Corp.
Miami, Florida, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, United States
Perimeter North Medical Research
Roswell, Georgia, United States
MacNeal Center for Clinical Research
Berwyn, Illinois, United States
Venture Resource Group
Overland Park, Kansas, United States
Cotton-O'Neil Clinical Research Center Topeka KS United States
Topeka, 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
Fallon Clinic Worcester MA United States
Worcester, Massachusetts, United States
Southwestern Medical Clinic
Bridgman, Michigan, United States
Clarkston Medical Group
Clarkston, Michigan, United States
Michigan State University - Kalamazoo Ctr for Med Studies
Kalamazoo, Michigan, United States
Mississippi Medical Research, LLC
Picayune, Mississippi, United States
ClinVest Research
Springfield, Missouri, United States
St. John's Clinic - Medical Research
Springfield, Missouri, United States
Montana Medical Research
Missoula, Montana, 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
Endwell Family Physician
Endwell, New York, United States
*Private Practice* Staten Island
Staten Island, New York, United States
Medical Frontiers LLC
Carlisle, Ohio, United States
Radiant Research
Greer, South Carolina, United States
Southwind Medical Specialists Memphis TN United States
Memphis, Tennessee, United States
Dallas Diabetic and Endocrinology Research Center
Dallas, Texas, United States
Radiant Research - North Dallas
Dallas, Texas, United States
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
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
Health Sciences Centre - Diabetes Research Group
Winnipeg, Manitoba, Canada
Rivergrove Medical Clinic
Winnipeg, Manitoba, Canada
Credit Valley Prof Bldg
Mississauga, Ontario, Canada
Hamilton Medical Research Group
Sherbrooke, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Institut de Recherches Cliniques
Montreal, Quebec, Canada
Clinique Médicale Millénia Santé
Québec, Quebec, Canada
CHUS - Hopital Fleurimont
Sherbrooke, Quebec, Canada
Azienda Ospedaliera-Ospedali Riuniti di Bergamo
Bergamo, Italy
Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio
Chieti, Italy
A.O.Polo Universitario Luigi Sacco
Milan, Italy
Istituto Scientifico San Raffaele - IRCCS
Milan, Italy
Ospedale S.Giovanni di Dio
Olbia, Italy
Presidio Ospedaliero di Cisanello Università degli Studi
Pisa, Italy
Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale
Roma, Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej
Oława, Poland
Policlinica Dr. Luis Rodriguez Carrasquillo
Carolina, Puerto Rico
Endocrine Lipid Diabetes Research Institute Ponce PR United States
Ponce, Puerto Rico
Miguel Sosa-Padilla, M.D.
San Juan, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2009
First Posted
May 14, 2009
Study Start
April 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
January 9, 2013
Record last verified: 2013-01