Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients
Overview[ - collapse ][ - ]
Purpose | This was a four month dose ranging study followed by a 24 to 48 month extension at the selected dose to characterize the safety and efficacy of the injectable IL-1B (interleukin 1, beta) antagonist canakinumab in the treatment of patients with Type 2 diabetes mellitus (T2DM) already treated on maximum dose metformin. |
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Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Canakinumab Drug: Metformin Drug: Placebo |
Phase | Phase 2/Phase 3 |
Sponsor | Novartis |
Responsible Party | Novartis |
ClinicalTrials.gov Identifier | NCT00900146 |
First Received | May 6, 2009 |
Last Updated | January 17, 2012 |
Last verified | January 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | May 6, 2009 |
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Last Updated Date | January 17, 2012 |
Start Date | April 2009 |
Estimated Primary Completion Date | November 2010 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients |
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Official Title | Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration for the Treatment of Hyperglycemia in Metformin Monotherapy Treated Type 2 Diabetic Patients: a Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study |
Brief Summary | This was a four month dose ranging study followed by a 24 to 48 month extension at the selected dose to characterize the safety and efficacy of the injectable IL-1B (interleukin 1, beta) antagonist canakinumab in the treatment of patients with Type 2 diabetes mellitus (T2DM) already treated on maximum dose metformin. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Diabetes Mellitus, Type 2 |
Intervention | Drug: Canakinumab Canakinumab lyophilized cake (25 mg and 150 mg in individual 6 mL glass vials ) was reconstituted and then used to dilute the 25mg or 150mg solutions to make 5mg, 15mg and 50mg injections. Drug: Metformin Before randomization, in drug naïve patients at a dose of 1000 mg with the evening meal or 500 mg b.i.d. (twice daily) with two main meals. At the randomization visit, patients were prescribed with no less than 1,000mg/day. Drug: Placebo Placebo lyophilized cake will be reconstituted and then used to dilute the 25mg or 150mg solutions to make 5mg, 15mg and 50mg injections. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Terminated |
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Estimated Enrollment | 556 |
Estimated Completion Date | November 2010 |
Estimated Primary Completion Date | November 2010 |
Eligibility Criteria | Inclusion Criteria: 1. Patients must have a documented diagnosis of Type 2 diabetes confirmed by World Health Organization (WHO) criteria either a FPG≥ 7.0 mmol/l (126 mg/dl) or an Oral glucose tolerance test (OGTT) test 2-hour PG ≥ 11.1 mmol/l (200 mg/dl). 2. Patients must: - be naïve to anti-diabetes drug therapy (except for short term treatment courses with insulin in connection with hospitalization, etc.) - meet protocol specified Glycosylated hemoglobin / hemoglobin A1c (HbA1c) criteria - be eligible for metformin monotherapy OR - be on stable metformin monotherapy treatment for at least three months at Screening - meet protocol specified HbA1c criteria - take metformin as their first and only treatment with anti-diabetes drug therapy OR - be taking an AGI as their first and only anti-diabetes drug therapy (except short term treatment courses with insulin in connection with hospitalizations, etc) - meet protocol specified HbA1c criteria - be eligible for metformin monotherapy 3. Patients must have a morning fasting plasma glucose result < 180 mg/dl at Visit 3 (Month -1) analyzed by the Central Laboratory. 4. Were on a daily dose of metformin ≥ 1000 mg (or less according to local regulations) Exclusion Criteria: 1. Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes. 2. Any of the following significant laboratory abnormalities: - Serum Glutamic acid decarboxylase (GAD)-antibody positivity - Clinically significant Thyroid stimulating hormone (TSH) outside of normal range at Screening - Renal function indicating high risk metformin use, including serum creatinine concentrations (≥1.5 mg/dL for males, ≥1.4 mg/dL for females) or other evidence of abnormal creatinine clearance. - Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN), or total bilirubin > 2 x ULN and/or direct bilirubin > ULN at Screening, confirmed with repeat measure within one week. 3. History or current findings of active pulmonary disease as evidenced by a history of positive purified protein derivative (PPD), QuantiFERON-TB Gold (QFT-G), AFB sputum or positive PPD followed by positive chest x-ray or QFT-G, or ongoing antibiotic treatment for latent TB. 4. Risk factors for TB as defined in protocol 5. Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment proven or suspected to be related to immunocompromise including HIV or active or recurrent Hepatitis B and Hepatitis C. 6. Systemic or local treatment of any immune modulating agent in doses with systemic effects or live vaccinations within 3 months 7. Stroke, myocardial infarction, acute coronary syndrome, revascularization procedure or recurrent TIA within the last 6 months. 8. Unwillingness to use insulin glargine as the additional medication should glycemic control deteriorate. 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, Belgium, China, Germany, Hungary, India, Japan, Korea, Republic of, Peru, Romania, South Africa, Turkey, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00900146 |
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Other Study ID Numbers | CACZ885I2202 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | Novartis |
Study Sponsor | Novartis |
Collaborators | Not Provided |
Investigators | Study Director: Novartis Pharmaceuticals Corporation Sponsor GmbH |
Verification Date | January 2012 |
Locations[ + expand ][ + ]
Anasazi Internal Medicine | Phoenix, Arizona, United States |
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Whittier Institute of Diabetes | La Jolla, California, United States |
Novartis Investigative Site | Los Gatos, California, United States |
Novartis Investigative Site | Santa Monica, California, United States, 90404 |
Orange County Research Center | Tustin, California, United States |
Novartis Investigative Site | Atlanta, Georgia, United States |
Deaconess Clinic | Evansville, Indiana, United States |
Novartis Investigative Site | Jackson, Mississippi, United States |
Novartis Investigative Site | Picayune, Mississippi, United States |
Novartis Investigative Site | Trenton, New Jersey, United States |
Diabetes Research Center | Columbus, Ohio, United States |
Tri-State Medical Group | Beaver, Pennsylvania, United States |
Preferred Primary Care Physicians | Pittsburgh, Pennsylvania, United States |
Novartis Investigative Site | Columbia, South Carolina, United States |
R/D Clinical Research | Lake Jackson, Texas, United States |
Novartis Investigative Site | Pasadena, Texas, United States |
Novartis Investigative Site | San Antonio, Texas, United States |
Medical Research Initiatives Inc | Virginia Beach, Virginia, United States |
Clinica de Fracturas y Ortopedia | Mar del Plata, Buenos Aires, Argentina, C1100ABB |
DIM Clinica Privada | Buenos Aires, Argentina, B1704ETD |
Centro Medico Viamonte | Buenos Aires, Argentina, C1120AAC |
Consultorios Asociados de Endocrinologia | Buenos Aires, Argentina, C1425AGC |
Hospital Juan Ramon Vidal | Corrientes, Argentina, W3410AVV |
Novartis Investigative Site | Rosario Santa Fe, Argentina, S2000AII |
Instituto de Investigaciones Biomedicas | Santa Fe, Argentina, S3000FNF |
Centro de Investigaciones Clinicas del Litoral | Santa Fe, Argentina, S3000FWO |
Private Practice - DEMEULEMEESTER | Gozée, Belgium |
Novartis Investigative Site | Heist-op-den-berg, Belgium |
UZ Brussel | Jette, Belgium |
Novartis Investigative Site | Hong Kong, China |
Praxis F. Franzmann | Bad Oeynhausen, Germany, 32549 |
emovis GmbH | Berlin, Germany, 10629 |
Praxis Dr. Stütz | Bretten, Germany, 75015 |
GWT-TUB GmbH | Dresden, Germany, 01307 |
Gemeinschaftspraxis und Dialysezentrum Karlstraße | Düsseldorf, Germany |
Asklepios Klinik St. Georg | Hamburg, Germany, 20099 |
Städt. Kankenhaus Nordstadt | Hannover, Germany, 30167 |
Diabeteszentrum Hohenmölsen | Hohenmölsen, Germany, 06679 |
Johannes Gutenberg-Universität Mainz | Mainz, Germany, 55101 |
Zentrum für Klinische Forschung Neuwied (ZKSN) | Neuwied, Germany, 56564 |
Praxis Dr. Wunderer | Nürnberg, Germany, 90489 |
Praxis Dr. Kosch | Pirna, Germany, 01796 |
Praxis Dr. Alawi | Saarlouis, Germany, 66740 |
Praxis Dr. Klein | Schenklengsfeld, Germany, 36277 |
Forschungszentrum Ruhr, KliFoCenter GmbH | Witten, Germany, 58455 |
Sandor Karolyi Hospital | Budapest, Hungary |
Semmelweiss Medical University | Budapest, Hungary |
Fővárosi Önkormányzat Péterfy Sándor Utcai Kórház - Rendelőintézet és Baleseti Központ | Budapest, Hungary |
Kenezy Gyula Korhaz | Debrecen, Hungary |
Szegedi Egyetem | Szeged, Hungary |
Zala Megyei Korhaz | Zalaegerszeg, Hungary |
Bangalore Diabetes Hospital | Bangalore, India |
Jnana Sanjeevini Medical Center | Bangalore, India |
SAMATVAM | Bangalore, India |
Gokula Metropolis Clinical Research Centre | Bangalore-, India |
Madras Diabetes Reasearch Foundation | Chennai, India |
Amrita Institute of Medical Sciences and Research Center | Cochin, India |
Nizam's Institute of Medical Sciences | Hyderabaad, India |
Diabetes Thyroid Hormone Research Institute Pvt. Ltd. | Indore, India |
S R Kalla Memorial Gastro & General Hospital | Jaipur, India |
Pitale Diabetes & Hormone Centre | Nagpur, India |
Health and Research Centre | Trivandrum, India |
King George Hospital | Visakhapatnam, India |
National Hospital Organization Nagoya Medical Center | Nagoya, Aichi, Japan, 460-0001 |
Kyushu Rosai Hospital | Kitakyushu, Fukuoka, Japan, 800-0296 |
NHO Yokohama Medical Center | Yokohama, Kanagawa, Japan, 245-8575 |
Musashikoganei Clinic | Koganei-city, Tokyo, Japan, 184-0004 |
Novartis Investigative Site | Minato-ku, Tokyo, Japan |
Fujikoshi Hospital | Toyama-city, Toyama, Japan, 930-0964 |
Saiseikai Fukuoka General Hospital | Fukuoka, Japan, 810-0001 |
Kokura Medical Center | Kitakyusyu, Japan |
Seino Internal Medicine Clinic | Koriyama, Japan |
Geriatrics Research Institute Hospital | Maebashi, Japan |
Takagi Hospital | Ohkawa, Japan |
Sakai Hospital Kinki University School of Medicine | Sakai, Japan |
Novartis Investigative Site | Pusan, Korea, Republic of, 614-735 |
Novartis Investigative Site | Seoul, Korea, Republic of, 135-720 |
Novartis Investigative Site | Seoul, Korea, Republic of, 139-872 |
Novartis Investigative Site | Seoul, Korea, Republic of, 135-710 |
Novartis Investigative Site | Suwon, Korea, Republic of, 442-721 |
Instituto Delgado de Investigacion Medica | Arequipa, Peru |
Clinica Chiclayo | Chiclayo, Peru |
Hospital Nacional Cayetano Heredia | San Martin de Porres, Peru |
Centro de Investigacion Clinica Trujillo | Trujillo, Peru |
Ambulatory of Institute of Nutrition Diseases and Diabetes | Bucharest, Romania |
Medical Centre "Sanatatea ta" | Bucuresti, Romania |
Novartis Investigative Site | Bucuresti, Romania |
Policlinica Dr. Citu Timisoara | Timisoara, Romania |
203 Maxwell Centre | Durban, South Africa |
Parklands Medical Centre | Durban, South Africa |
St Augustines Medical Centre | Durban, South Africa |
Synapta Clinical Research Centre | Durban, South Africa |
Drs Essack and Mitha | Johannesburg, South Africa |
PE Greenacres Hospital | Port Elizabeth, South Africa |
26 Daffodil Street | Stanger, South Africa |
Ankara Ataturk Training and Research Hospital | Ankara, Turkey |
Hacettepe University Medical Faculty | Ankara, Turkey |
S.B. Yildirim Beyazit Training and Research Hospital | Ankara, Turkey |
Gulhane Askeri Tip Akademisi | Ankara, Turkey |
Istanbul University Cardiology Institute | Istanbul, Turkey |
Ege University Medical Faculty | Izmir, Turkey |
Hayat Tip Merkezi (Hayat Medical Center) Deapartment of Internal Diseases | Karabuk, Turkey |
Morriston Hospital | Swansea, England, United Kingdom, SA6 6NL |
Birmingham Heartlands Hospital | Birmingham, United Kingdom |
Royal Bournemouth Hospital | Bournemouth, United Kingdom |
Rowden Medical Partnership | Wiltshire, United Kingdom |