CV Risk Reduction sub-study (Reduction in Recurrent Major CV disease)

Conditions: Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
atherosclerosis

Registration Number: EUCTR2012-003011-58-SK

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Written informed consent form
2. Meet main study eligibility criteria listed in Section 4.1 and 4.2 of protocol CACZ885M2301 and agreed to participate in CANTOS main study
3. T2D at baseline per CACZ885M2301 protocol criteria and be on a stable anti-hyperglycemic medication for at least 4 weeks prior to the baseline OGTT test
4. Willing to have the OGTT assessment started before 10 am

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

• Pregnant or nursing (lactation) women
• Women of child-bearing potential
• Any of the following concomitent diseases:
1. Planned coronary revascularization
2. major non cardiac surgical or endoscopic procedure within past 6 months
• Uncontrolled hypertension

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care increases insulin secretion and insulin sensitivity<br><br>;Secondary Objective: Not applicable;Primary end point(s): Change from baseline of the insulin secretion rate (ISR) relative to glucose 0-30 min defined as ?30 = AUCISR 0-30 / AUCGluc 0-30 averaged across the yearly visits.;Timepoint(s) of evaluation of this end point: 36 months

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: 36 months;Secondary end point(s): Change from baseline in:<br>• Insulin sensitivity index<br>• OGTT stimulated area under curve (AUC) 0-120 min of glucose concentration, insulin concentration, pro insulin concentration<br>and insulin concentration/glucose concentration ratio<br>• fasting pro-insulin concentration /insulin concentration ratio<br>• OGTT stimulated area under the curve (AUC) 0-120 min of C-peptide concentration<br>