A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)
Overview[ - collapse ][ - ]
| Purpose | This study will assess the effect of LCQ when added to metformin. |
|---|---|
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: LCQ908A Drug: LCQ908A Drug: LCQ908A Drug: LCQ908A Drug: LCQ908A Drug: Placebo Drug: Sitagliptin Drug: metformin |
| Phase | Phase 2 |
| Sponsor | Novartis Pharmaceuticals |
| Responsible Party | Novartis |
| ClinicalTrials.gov Identifier | NCT00901979 |
| First Received | May 13, 2009 |
| Last Updated | January 3, 2013 |
| Last verified | January 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 13, 2009 |
|---|---|
| Last Updated Date | January 3, 2013 |
| Start Date | April 2009 |
| Estimated Primary Completion Date | June 2010 |
| Current Primary Outcome Measures | Effect of LCQ on measures of glucose control [Time Frame: 12 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM) |
|---|---|
| Official Title | Not Provided |
| Brief Summary | This study will assess the effect of LCQ when added to metformin. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Type 2 Diabetes Mellitus |
| Intervention | Drug: LCQ908A Drug: LCQ908A Drug: LCQ908A Drug: LCQ908A Drug: LCQ908A Drug: Placebo Drug: Sitagliptin Drug: metformin |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 693 |
| Estimated Completion Date | June 2010 |
| Estimated Primary Completion Date | June 2010 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Argentina, Canada, Italy, Poland, Puerto Rico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00901979 |
|---|---|
| Other Study ID Numbers | CLCQ908A2203 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Novartis |
| Study Sponsor | Novartis Pharmaceuticals |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | January 2013 |
Locations[ + expand ][ + ]
| Mesa Family Medical Center/Clinical Research Advantage | Mesa, Arizona, United States |
|---|---|
| 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 |
| St. John's Clinic - Medical Research | Springfield, Missouri, United States |
| ClinVest 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 |
| Texas Center for Drug Development, P.A. | Houston, Texas, United States |
| Blalock Clinical Research | Houston, Texas, United States |
| Accurate Clinical Research | 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 |
| Rivergrove Medical Clinic | Winnipeg, Manitoba, Canada |
| Health Sciences Centre - Diabetes Research Group | 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 | Milano, Italy |
| Istituto Scientifico San Raffaele - IRCCS | Milano, 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 | Olawa, 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 |