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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02044848
Recruitment Status : Terminated (This study was terminated prematurely by the Sponsor for business reasons only.)
First Posted : January 24, 2014
Results First Posted : October 9, 2015
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus
Interventions Drug: Secukinumab
Drug: Placebo
Enrollment 5
Recruitment Details Only adult patients were enrolled (no pediatrics as planned) and no one completed the planned treatment period.
Pre-assignment Details  
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Period Title: Overall Study
Started 2 3
Completed 0 0
Not Completed 2 3
Reason Not Completed
Administrative Problems             2             3
Arm/Group Title Secukinumab Placebo Total
Hide Arm/Group Description Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year Total of all reporting groups
Overall Number of Baseline Participants 2 3 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 3 participants 5 participants
24  (4.24) 24  (1.73) 24  (2.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 3 participants 5 participants
Female
1
  50.0%
1
  33.3%
2
  40.0%
Male
1
  50.0%
2
  66.7%
3
  60.0%
1.Primary Outcome
Title Stimulated C-peptide in Response to a Standard Mixed Meal Tolerance Test
Hide Description Study was terminated and no data were collected for the Outcome Measure.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated and no data were collected for the Outcome Measure
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description:
Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Secukinumab Placebo
Hide Arm/Group Description Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
All-Cause Mortality
Secukinumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Secukinumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Secukinumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   2/2 (100.00%)   2/3 (66.67%) 
Blood and lymphatic system disorders     
Eosinophilia  1  1/2 (50.00%)  0/3 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  1/2 (50.00%)  0/3 (0.00%) 
Diarrhoea  1  0/2 (0.00%)  1/3 (33.33%) 
General disorders     
Fatigue  1  1/2 (50.00%)  0/3 (0.00%) 
Infections and infestations     
Upper respiratory tract infection  1  1/2 (50.00%)  1/3 (33.33%) 
Investigations     
Blood ketone body  1  0/2 (0.00%)  1/3 (33.33%) 
Skin and subcutaneous tissue disorders     
Rash  1  1/2 (50.00%)  0/3 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02044848     History of Changes
Other Study ID Numbers: CAIN457A2227
First Submitted: January 22, 2014
First Posted: January 24, 2014
Results First Submitted: September 9, 2015
Results First Posted: October 9, 2015
Last Update Posted: February 17, 2016