- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00901979
A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
January 3, 2013 updated by: Novartis Pharmaceuticals
This study will assess the effect of LCQ when added to metformin.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
693
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada
- Health Sciences Centre - Diabetes Research Group
-
Winnipeg, Manitoba, Canada
- Rivergrove Medical Clinic
-
-
Ontario
-
Mississauga, Ontario, Canada
- Credit Valley Prof Bldg
-
Sherbrooke, Ontario, Canada
- Hamilton Medical Research Group
-
-
Quebec
-
Montreal, Quebec, Canada
- Hopital Maisonneuve-Rosemont
-
Montreal, Quebec, Canada
- Institut de Recherches Cliniques
-
Québec, Quebec, Canada
- Clinique Médicale Millénia Santé
-
Sherbrooke, Quebec, Canada
- CHUS - Hôpital Fleurimont
-
-
-
-
-
Bergamo, Italy
- Azienda Ospedaliera-Ospedali Riuniti di Bergamo
-
Chieti, Italy
- Centro Studi sull'Invecchiamento CeSI-Univers.G.D'Annunzio
-
Milano, Italy
- A.O.Polo Universitario Luigi Sacco
-
Milano, Italy
- Istituto Scientifico San Raffaele - IRCCS
-
Olbia, Italy
- Ospedale S.Giovanni di Dio
-
Pisa, Italy
- Presidio Ospedaliero di Cisanello Università degli Studi
-
Roma, Italy
- Univ.Tor Vergata - AUSL ROMA B - Sede Territoriale
-
-
-
-
-
Olawa, Poland
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej
-
-
-
-
-
Carolina, Puerto Rico
- Policlinica Dr. Luis Rodriguez Carrasquillo
-
Ponce, Puerto Rico
- Endocrine Lipid Diabetes Research Institute Ponce PR United States
-
San Juan, Puerto Rico
- Miguel Sosa-Padilla, M.D.
-
-
-
-
Arizona
-
Mesa, Arizona, United States
- Clinical Research Advantage
-
Mesa, Arizona, United States
- Mesa Family Medical Center/Clinical Research Advantage
-
-
Arkansas
-
Little Rock, Arkansas, United States
- Woodland International Reserach Group, LLC
-
-
California
-
Buena Park, California, United States
- Associated Pharmaceutical Research
-
Concord, California, United States
- John Muir Clinical Research
-
Pasadena, California, United States
- *Private Practice*
-
Riverside, California, United States
- Apex Research of Riverside
-
San Diego, California, United States
- California Research Foundation
-
San Diego, California, United States
- CNRI-San Diego, LLC
-
Tustin, California, United States
- Orange County Research Center
-
Walnut Creek, California, United States
- Diablo Clinical
-
-
Colorado
-
Denver, Colorado, United States
- Denver VA Medical Center
-
Northglenn, Colorado, United States
- Complete Family Care
-
-
Florida
-
Miami, Florida, United States
- Research Center Phase I-IV of Florida, Corp.
-
West Palm Beach, Florida, United States
- Metabolic Research Institute, Inc.
-
-
Georgia
-
Roswell, Georgia, United States
- Perimeter North Medical Research
-
-
Illinois
-
Berwyn, Illinois, United States
- MacNeal Center for Clinical Research
-
-
Kansas
-
Overland Park, Kansas, United States
- Venture Resource Group
-
Topeka, Kansas, United States
- Cotton-O'Neil Clinical Research Center Topeka KS United States
-
-
Kentucky
-
Bowling Green, Kentucky, United States
- Graves Gilbert Clinic Bowling Green KY United States
-
Madisonville, Kentucky, United States
- Commonwealth Biomedical Research, LLC
-
-
Maryland
-
Elkridge, Maryland, United States
- Centennial Medical Group
-
Towson, Maryland, United States
- International Research Center Towson MD United States
-
-
Massachusetts
-
Worcester, Massachusetts, United States
- Fallon Clinic Worcester MA United States
-
-
Michigan
-
Bridgman, Michigan, United States
- Southwestern Medical Clinic
-
Clarkston, Michigan, United States
- Clarkston Medical Group
-
Kalamazoo, Michigan, United States
- Michigan State University - Kalamazoo Ctr for Med Studies
-
-
Mississippi
-
Picayune, Mississippi, United States
- Mississippi Medical Research, LLC
-
-
Missouri
-
Springfield, Missouri, United States
- Clinvest Research
-
Springfield, Missouri, United States
- St. John's Clinic - Medical Research
-
-
Montana
-
Missoula, Montana, United States
- Montana Medical Research
-
-
Nebraska
-
Omaha, Nebraska, United States
- Meera Dewan, P.C.
-
-
New Jersey
-
Brick, New Jersey, United States
- Libra Clinical Research Associates
-
Toms River, New Jersey, United States
- Physicians Research Center
-
-
New York
-
Endwell, New York, United States
- Endwell Family Physician
-
Staten Island, New York, United States
- *Private Practice* Staten Island
-
-
Ohio
-
Carlisle, Ohio, United States
- Medical Frontiers LLC
-
-
South Carolina
-
Greer, South Carolina, United States
- Radiant Research
-
-
Tennessee
-
Memphis, Tennessee, United States
- Southwind Medical Specialists Memphis TN United States
-
-
Texas
-
Dallas, Texas, United States
- Dallas Diabetic and Endocrinology Research Center
-
Dallas, Texas, United States
- Radiant Research - North Dallas
-
Houston, Texas, United States
- Accurate Clinical Research
-
Houston, Texas, United States
- Blalock Clinical Research
-
Houston, Texas, United States
- Texas Center For Drug Development, P.A.
-
-
Virginia
-
Ettrick, Virginia, United States
- Ettrick Health Center
-
Richmond, Virginia, United States
- McGuire Veterans Medical Center
-
-
Washington
-
Bellevue, Washington, United States
- Northwest Clinical Research
-
Monroe, Washington, United States
- Providence Physicians Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: LCQ908 Dose 1
|
|
Experimental: LCQ908 Dose 2
|
|
Experimental: LCQ908 Dose 3
|
|
Experimental: LCQ908 Dose 4
|
|
Experimental: LCQ908 Dose 5
|
|
Active Comparator: Sitagliptin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effect of LCQ on measures of glucose control
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in body weight and related measures
Time Frame: 12 weeks
|
12 weeks
|
Insulin sensitivity
Time Frame: 12 weeks
|
12 weeks
|
Safety and tolerability
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
May 13, 2009
First Submitted That Met QC Criteria
May 13, 2009
First Posted (Estimate)
May 14, 2009
Study Record Updates
Last Update Posted (Estimate)
January 9, 2013
Last Update Submitted That Met QC Criteria
January 3, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Hypoglycemic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Protease Inhibitors
- Incretins
- Dipeptidyl-Peptidase IV Inhibitors
- Metformin
- Sitagliptin Phosphate
Other Study ID Numbers
- CLCQ908A2203
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
HighTide Biopharma Pty LtdRecruitingT2DM (Type 2 Diabetes Mellitus)China
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States