Trial Outcomes & Findings for Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus (NCT NCT02044848)

NCT ID: NCT02044848

Last Updated: 2016-02-17

Results Overview

Study was terminated and no data were collected for the Outcome Measure.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 5 participants
• Primary outcome timeframe: Week 52
• Results posted on: 2016-02-17

Participant Flow

Only adult patients were enrolled (no pediatrics as planned) and no one completed the planned treatment period.

Participant milestones

Measure	Secukinumab Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year	Placebo Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Overall Study STARTED	2	3
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Secukinumab Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year	Placebo Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Overall Study Administrative Problems	2	3

Baseline Characteristics

Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus

Baseline characteristics by cohort

Measure	Secukinumab n=2 Participants Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year	Placebo n=3 Participants Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year	Total n=5 Participants Total of all reporting groups
Age, Continuous	24 years STANDARD_DEVIATION 4.24 • n=5 Participants	24 years STANDARD_DEVIATION 1.73 • n=7 Participants	24 years STANDARD_DEVIATION 2.45 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 52

Population: Study was terminated and no data were collected for the Outcome Measure

Study was terminated and no data were collected for the Outcome Measure.

Outcome measures

Outcome data not reported

Adverse Events

Secukinumab

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Secukinumab n=2 participants at risk Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year	Placebo n=3 participants at risk Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Blood and lymphatic system disorders Eosinophilia	50.0% 1/2	0.00% 0/3
Gastrointestinal disorders Abdominal pain	50.0% 1/2	0.00% 0/3
Gastrointestinal disorders Diarrhoea	0.00% 0/2	33.3% 1/3
General disorders Fatigue	50.0% 1/2	0.00% 0/3
Infections and infestations Upper respiratory tract infection	50.0% 1/2	33.3% 1/3
Investigations Blood ketone body	0.00% 0/2	33.3% 1/3
Skin and subcutaneous tissue disorders Rash	50.0% 1/2	0.00% 0/3

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER