Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients

Stopped early · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT00900146

Run by

Novartis

People needed

556

Starts

2009-04-01

Expected to finish

2010-11-01

Last updated by the study team

2012-02-20

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).
• 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
• Patients must have a morning fasting plasma glucose result < 180 mg/dl at Visit 3 (Month -1) analyzed by the Central Laboratory.
• Were on a daily dose of metformin ≥ 1000 mg (or less according to local regulations)

You may not qualify if…

• Type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes.
• 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.
• 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.
• Risk factors for TB as defined in protocol
• 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.
• Systemic or local treatment of any immune modulating agent in doses with systemic effects or live vaccinations within 3 months
• Stroke, myocardial infarction, acute coronary syndrome, revascularization procedure or recurrent TIA within the last 6 months.
• Unwillingness to use insulin glargine as the additional medication should glycemic control deteriorate.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• 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
• DIM Clinica Privada — Buenos Aires, Buenos Aires, Argentina
• Centro Medico Viamonte — Buenos Aires, Buenos Aires, Argentina
• Consultorios Asociados de Endocrinologia — Buenos Aires, Buenos Aires, Argentina
• Clinica de Fracturas y Ortopedia — Mar del Plata, Buenos Aires, Argentina
• Hospital Juan Ramon Vidal — Corrientes, Corrientes Province, Argentina
• Instituto de Investigaciones Biomedicas — Santa Fe, Santa Fe Province, Argentina
• Centro de Investigaciones Clinicas del Litoral — Santa Fe, Santa Fe Province, Argentina
• Anasazi Internal Medicine — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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