Diabetes Mellitus, Type 2
Conditions
Interventions
investigational material(s)
Generic name etc : Canakinumab
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigational material
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have a documented diagnosis of Type 2 diabetes confirmed by WHO criteria either a FPG >= 7.0 mmol/l (126 mg/dl) or an OGTT test 2-hour PG >= 11.1 mmol/l (200 mg/dl). 2. Patients must: - be naive to anti-diabetes drug therapy (except for short term treatment courses with insulin in connection with hospitalization, etc.) - meet protocol specified 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 alpha-glucosidase inhibitor as their first and only treatment with anti-diabetes drug therapy - meet protocol specified HbA1c criteria
Exclusion criteria
Exclusion criteria: 1. Any of the following significant laboratory abnormalities: - Serum GAD-antibody positivity - Clinically significant 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. - ALT and/or AST > 2 x upper limit of normal (ULN) at Screening, confirmed with repeat measure within one week. 2. History or current findings of active pulmonary disease 3. Risk factors for TB as defined in protocol 4. Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment 5. Stroke, myocardial infarction, acute coronary syndrome, revascularization procedure or recurrent TIA within the last 6 months. 6. Unwillingness to use insulin glargine as the additional medication should glycemic control deteriorate. Other protocol- defined inclusion/exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, tolerability, HbA1c To assess safety and tolerability of four doses of ACZ885 vs. placebo over 4 months in patients with T2DM To assess the effect on HbA1c of four doses of ACZ885 vs. placebo as an add-on regimen over 4 months in patients with T2DM | — |
Secondary
| Measure | Time frame |
|---|---|
| FPG, C-peptide, insulin, 7-point glucose meter data, hsCRP, cardiovascular events, infections To evaluate the effect of 4-month treatment of ACZ885 at 4 doses vs. placebo on the following variables: - Glucose, C-peptide and insulin following meal test - 7-point glucose meter data - hsCRP To evaluate the effect of 4-month treatment of ACZ885 at 4 doses vs. placebo on cardiovascular events and infections | — |
Outcome results
None listed