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

A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP: OGTT (Oral Glucose Tolerance Test) study to examine the long term effects (3-4 years) of canakinumab in T2DM on endogenous insulin secretion and insulin resistance. - CANTOS sub-study 2

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003011-58-DE

Enrollment

300

Registered

2012-10-16

Start date

2012-12-10

Completion date

Unknown

Last updated

2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 ;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	—

Measure

Time frame

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 ;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

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Secondary

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

Measure

Time frame

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

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Countries

Germany, Hungary, Italy, Slovakia, United States

Contacts

Public ContactMedizinischer Infoservice

Novartis Pharma GmbH

infoservice.novartis@novartis.com+491802232300

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026