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

• Register: JPRN
• Last refreshed on: 26 April 2013
• Main ID: JPRN-JapicCTI-090828
• Date of registration: 21/06/2011
• Primary sponsor: Novartis Pharma K.K.
• Public title: Dose Finding, Safety and Efficacy of Monthly Subcutaneous Canakinumab Administration in Metformin Monotherapy Treated Type 2 Diabetic Patients
• Scientific 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
• Date of first enrolment: 01/04/2009
• Target sample size: 600
• Recruitment status: Complete
• URL: http://www.clinicaltrials.jp/user/showCteDetailE.jsp?japicId=JapicCTI-090828
• Study type: INTERVENTIONAL
• Study design: Treatment, Randomized, Double-Blind, Parallel Assignment

Countries of recruitment

Japan

Contacts

• Affiliation: Novartis Pharma KK Novartis direct

Key inclusion & exclusion 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: 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

Age minimum: 18
Age maximum: 74
Gender: BOTH

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Primary Outcome(s)

safety, tolerability, HbA1c

Secondary Outcome(s)

FPG, C-peptide, insulin, 7-point glucose meter data, hsCRP, cardiovascular events, infections

Secondary ID(s)

NCT00900146