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

• Register: EUCTR
• Last refreshed on: 10 February 2014
• Main ID: EUCTR2012-003011-58-IT
• Date of registration: 25/10/2012
• Prospective Registration: Yes
• Primary sponsor: NOVARTIS FARMA
• 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: An OGTT sub-study evaluating the effect of canakinumab on insulin secretion rate and other glucose control parameters following an oral glucose tolerance test in Type 2 diabetics
• Date of first enrolment: 19/12/2012
• 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: no Other: yes Other specify the comparator: it's a substudy, no drug - same IMP used at different dosage Number of treatment arms in the trial: 3

Countries of recruitment

Germany, Hungary, Italy, United States

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Farma

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Farma

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: 0
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
MedDRA version: 14.1 Level: LLT Classification code 10003601 Term: Atherosclerosis System Organ Class: 100000004866

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

Intervention(s)

Trade Name: ILARIS*SC 1FL 150MG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Secondary Objective: Not applicable to substudy

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

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)

2012-003011-58-DE

CACZ885M2301S2

Source(s) of Monetary Support

Novartis