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

• Register: EUCTR
• Last refreshed on: 17 March 2014
• Main ID: EUCTR2012-003011-58-DE
• Date of registration: 16/10/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: CV Risk Reduction sub-study (Reduction in Recurrent Major CV disease)
• Scientific title: 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
• Date of first enrolment: 10/12/2012
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003011-58
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 3

Countries of recruitment

Germany, Hungary, Italy, Slovakia, United States

Contacts

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

• Name: Medizinischer Infoservice
• Affiliation: Novartis Pharma GmbH

Key inclusion & exclusion 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:
• 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

atherosclerosis

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

Intervention(s)

Pharmaceutical Form:

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

CACZ885M2301S2

Source(s) of Monetary Support

Novartis Pharma Services AG