CV Risk Reduction sub-study (Reduction in Recurrent Major CV disease)
- Conditions
- atherosclerosisTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-003011-58-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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
• 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 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>;Timepoint(s) of evaluation of this end point: 36 months