A 12 Week Study in Patients With Type 2 Diabetes Mellitus (T2DM)

Type 2 Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901979
• Other study ID #: CLCQ908A2203
• Status: Completed
• Phase: Phase 2
• First received: May 13, 2009
• Last updated: January 3, 2013
• Start date: April 2009
• Est. completion date: June 2010

Study information

• Verified date: January 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesIndia: Ministry of HealthItaly: The Italian Medicines AgencyMexico: Ministry of HealthPeru: General Directorate of Pharmaceuticals, Devices, and DrugsPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian FederationSlovakia: State Institute for Drug ControlSpain: Spanish Agency of MedicinesTurkey: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 693
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• LCQ908A

• LCQ908A

• LCQ908A

• LCQ908A

• LCQ908A

• Placebo

• Sitagliptin

• metformin

Locations

Country	Name	City	State
Canada	Credit Valley Prof Bldg	Mississauga	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	Hamilton Medical Research Group	Sherbrooke	Ontario
Canada	Health Sciences Centre - Diabetes Research Group	Winnipeg	Manitoba
Canada	Rivergrove Medical Clinic	Winnipeg	Manitoba
Italy	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
Poland	Samodzielny Publiczny Zaklad Opieki Zdrowotnej	Olawa
Puerto Rico	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
United States	Northwest Clinical Research	Bellevue	Washington
United States	MacNeal Center for Clinical Research	Berwyn	Illinois
United States	Graves Gilbert Clinic Bowling Green KY United States	Bowling Green	Kentucky
United States	Libra Clinical Research Associates	Brick	New Jersey
United States	Southwestern Medical Clinic	Bridgman	Michigan
United States	Associated Pharmaceutical Research	Buena Park	California
United States	Medical Frontiers LLC	Carlisle	Ohio
United States	Clarkston Medical Group	Clarkston	Michigan
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	Denver VA Medical Center	Denver	Colorado
United States	Centennial Medical Group	Elkridge	Maryland
United States	Endwell Family Physician	Endwell	New York
United States	Ettrick Health Center	Ettrick	Virginia
United States	Radiant Research	Greer	South Carolina
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	Michigan State University - Kalamazoo Ctr for Med Studies	Kalamazoo	Michigan
United States	Woodland International Reserach Group, LLC	Little Rock	Arkansas
United States	Commonwealth Biomedical Research, LLC	Madisonville	Kentucky
United States	Southwind Medical Specialists Memphis TN United States	Memphis	Tennessee
United States	Clinical Research Advantage	Mesa	Arizona
United States	Mesa Family Medical Center/Clinical Research Advantage	Mesa	Arizona
United States	Research Center Phase I-IV of Florida, Corp.	Miami	Florida
United States	Montana Medical Research	Missoula	Montana
United States	Providence Physicians Group	Monroe	Washington
United States	Complete Family Care	Northglenn	Colorado
United States	Meera Dewan, P.C.	Omaha	Nebraska
United States	Venture Resource Group	Overland Park	Kansas
United States	*Private Practice*	Pasadena	California
United States	Mississippi Medical Research, LLC	Picayune	Mississippi
United States	McGuire Veterans Medical Center	Richmond	Virginia
United States	Apex Research of Riverside	Riverside	California
United States	Perimeter North Medical Research	Roswell	Georgia
United States	California Research Foundation	San Diego	California
United States	CNRI-San Diego, LLC	San Diego	California
United States	ClinVest Research	Springfield	Missouri
United States	St. John's Clinic - Medical Research	Springfield	Missouri
United States	*Private Practice* Staten Island	Staten Island	New York
United States	Physicians Research Center	Toms River	New Jersey
United States	Cotton-O'Neil Clinical Research Center Topeka KS United States	Topeka	Kansas
United States	International Research Center Towson MD United States	Towson	Maryland
United States	Orange County Research Center	Tustin	California
United States	Diablo Clinical	Walnut Creek	California
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida
United States	Fallon Clinic Worcester MA United States	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada,  Italy,  Poland,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of LCQ on measures of glucose control		12 weeks	No
Secondary	Changes in body weight and related measures		12 weeks	No
Secondary	Insulin sensitivity		12 weeks	No
Secondary	Safety and tolerability		12 weeks	Yes