Health Condition 1: null- Type 2 Diabetes Mellitus
Conditions
Interventions
Intervention1: Canakinumab: 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
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients must have a documented diagnosis of Type 2 diabetes confirmed by WHO criteria either a FPG greater than or equal to 7.0 mmol/l (126 mg/dl) or an OGTT test 2-hour PG greater than or equal to 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 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 3. Patients must have a morning fasting plasma glucose result < 180 mg/dl at Visit 3 (Month -1) analyzed by the Central Laboratory.
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. * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (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 |
|---|---|
| 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 T2DMTimepoint: Time Frame: 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of 4-month treatment of ACZ885 vs. placebo on cardiovascular events and infections.Timepoint: Time Frame: 4 months;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 ? hsCRPTimepoint: Time Frame: 4 months | — |
Countries
India
Contacts
Public ContactK Murugananthan
Outcome results
None listed