Trial Outcomes & Findings for Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes (NCT NCT00947427)

Last Updated: 2020-05-06

Results Overview

The primary outcome is the area under the stimulated C-peptide curve (AUC) based on data collected at time 0 to 2 hours of a 4-hour mixed meal glucose tolerance test (MMTT) conducted at the primary endpoint visit. The timed measurements are done at: 0, 15, 30 60, 90, and 120 minutes. The calculation for the concentration of c-peptide is a weighted average of the 6 timed measurements of c-peptide in nano-moles/Liter. We try to distinguish this calculation from the AUC by referring to it as the "AUC mean" and may be expressed algebraically as the AUC/(120 min.); thus, the units are the same as the y-axis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

12 months

Results posted on

2020-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Injection Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months	Canakinumab (Anti IL-1beta) canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Overall Study STARTED	22	49
Overall Study COMPLETED	21	45
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Injection Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months	Canakinumab (Anti IL-1beta) canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	0	1

Baseline Characteristics

Canakinumab Study in Individuals With Newly Diagnosed Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Injection n=22 Participants Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months	Canakinumab (Anti IL-1beta) n=49 Participants canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months	Total n=71 Participants Total of all reporting groups
Age, Continuous	12.4 years STANDARD_DEVIATION 6.4 • n=39 Participants	11.6 years STANDARD_DEVIATION 4.0 • n=41 Participants	11.8 years STANDARD_DEVIATION 4.8 • n=35 Participants
Sex: Female, Male Female	8 Participants n=39 Participants	25 Participants n=41 Participants	33 Participants n=35 Participants
Sex: Female, Male Male	14 Participants n=39 Participants	24 Participants n=41 Participants	38 Participants n=35 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Placebo Injection n=21 Participants Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months	Canakinumab (Anti IL-1beta) n=45 Participants canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
C-peptide Response to Mixed Meal Glucose Tolerance Test (MMTT) at One Year for Subjects Given Canakinumab Compared to Placebo	0.40 nmol/L Interval 0.3 to 0.49	0.41 nmol/L Interval 0.34 to 0.47

Adverse Events

Placebo Injection

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Canakinumab (Anti IL-1beta)

Serious events: 1 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Injection n=22 participants at risk Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months	Canakinumab (Anti IL-1beta) n=49 participants at risk canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Endocrine disorders Endocrine - Other	0.00% 0/22	2.0% 1/49 • Number of events 1
Nervous system disorders Seizure	4.5% 1/22 • Number of events 1	0.00% 0/49

Other adverse events

Other adverse events
Measure	Placebo Injection n=22 participants at risk Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months	Canakinumab (Anti IL-1beta) n=49 participants at risk canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
Blood and lymphatic system disorders Neutrophils/granulocytes (ANC/AGC)	13.6% 3/22 • Number of events 7	16.3% 8/49 • Number of events 12
Skin and subcutaneous tissue disorders Dermatology/Skin - Other	9.1% 2/22 • Number of events 2	12.2% 6/49 • Number of events 6
Gastrointestinal disorders Vomiting	13.6% 3/22 • Number of events 4	6.1% 3/49 • Number of events 3
Infections and infestations Infection - Other	27.3% 6/22 • Number of events 10	14.3% 7/49 • Number of events 9
Infections and infestations Infection with unknown ANC- Middle ear (otitis media)	4.5% 1/22 • Number of events 2	6.1% 3/49 • Number of events 4
Infections and infestations Infection with unknown ANC- Pharynx	9.1% 2/22 • Number of events 2	10.2% 5/49 • Number of events 5
Infections and infestations Infection with unknown ANC- Sinus	4.5% 1/22 • Number of events 1	8.2% 4/49 • Number of events 5
Infections and infestations Infection with unknown ANC- Skin (cellulitis)	13.6% 3/22 • Number of events 3	6.1% 3/49 • Number of events 4
Infections and infestations Infection with unknown ANC- Upper airway	13.6% 3/22 • Number of events 3	2.0% 1/49 • Number of events 1
Musculoskeletal and connective tissue disorders Fracture	0.00% 0/22	6.1% 3/49 • Number of events 3
General disorders Pain - Other	9.1% 2/22 • Number of events 3	8.2% 4/49 • Number of events 10

Additional Information

Carla Greenbaum

Benaroya Research Institute

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place