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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04774224




Registration number
NCT04774224
Ethics application status
Date submitted
22/02/2021
Date registered
1/03/2021

Titles & IDs
Public title
Baricitinib in New-onset Type 1 Diabetes
Scientific title
A Phase 2, Randomised, Placebo Controlled Study Investigating the Efficacy of Baricitinib in New Onset Type 1 Diabetes Mellitus
Secondary ID [1] 0 0
SVI-BARI-01
Universal Trial Number (UTN)
Trial acronym
BANDIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baricitinib
Treatment: Drugs - Placebo

Active comparator: Baricitinib - Baricitinib is an oral JAK1/JAK2-selective inhibitor. Dosage: The dose of baricitinib is 1 x 4mg tablet once daily Duration of administration: 48 weeks Mode of administration: Orally, with or without food

Placebo comparator: Placebo - One placebo tablet once daily for a duration of 48 weeks. Placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium and magnesium stearate.


Treatment: Drugs: Baricitinib
Participants will take one tablet of study drug per day for 48 weeks, and will be followed up for 48 weeks after study drug treatment has finished. Two-thirds of participants will receive Baricitinib.

Treatment: Drugs: Placebo
Participants will take one tablet of study drug per day for 48 weeks, and will be followed up for 48 weeks after study drug treatment has finished. One-third of participants will receive Placebo.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The primary endpoint of the study is the change from baseline of plasma C-peptide area under the curve (AUC) over 2 hours following a mixed meal.
Timepoint [1] 0 0
Measured at 48 weeks post commencement of intervention.
Secondary outcome [1] 0 0
Change from baseline in plasma C-peptide AUC over 2 hours following a mixed meal.
Timepoint [1] 0 0
Measured at weeks 12, 24, 72 and 96 post commencement of intervention.
Secondary outcome [2] 0 0
Change from baseline in mean daily insulin use over 7 consecutive days.
Timepoint [2] 0 0
Measured during the 2 weeks prior to the assessment at weeks 12, 24, 48, 72 and 96 post commencement of intervention.
Secondary outcome [3] 0 0
Change from baseline in glycosylated haemoglobin (HbA1c) levels.
Timepoint [3] 0 0
Measured at weeks 12, 24, 48, 72 and 96 post commencement of intervention.
Secondary outcome [4] 0 0
Number of participants with responder status. Responder status is defined as glycosylated haemoglobin (HbA1c) less than or equal to 6.5 percent and mean daily insulin use less than 0.5 international units per kilogram per day (IU/kg/day).
Timepoint [4] 0 0
Measured at weeks 12, 24, 48, 72 and 96 post commencement of intervention.
Secondary outcome [5] 0 0
Change in estimated C-peptide (CPEST) from baseline. CPEST is calculated based on six variable routine measures: disease duration, BMI, insulin dose, HbA1c, fasting plasma C-peptide and fasting plasma glucose.
Timepoint [5] 0 0
Measured at weeks 12, 24, 48, 72 and 96 post commencement of intervention.
Secondary outcome [6] 0 0
Continuous glucose monitoring (CGM).
Timepoint [6] 0 0
Measured at baseline, 12, 24, 48 and 96 weeks post commencement of intervention.
Secondary outcome [7] 0 0
The composite outcome assessing both the frequency, and when relevant, the severity of all adverse events.
Timepoint [7] 0 0
Adverse events will be monitored throughout the entire study duration at weeks 0, 2, 4, 8, 12, 16, 20, 24, 36, 48, 72 and 96.

Eligibility
Key inclusion criteria
1. Male or female aged between 10 and 30 years (inclusive) at screening;
2. Diagnosis of T1D according to ADA criteria within 100 days prior to starting study drug;
3. Islet autoantibody positivity (one or more of: GADA, IA-2A, IAA (assessed within one week of commencing insulin therapy), ZnT8A);
4. Stimulated (peak or 90 min) C-peptide >0.2 nM during a 2-hour MMTT at the screening visit; or random C-peptide result >0.3 nM during the screening period.
5. Participants of childbearing age who are sexually active must agree to use of effective birth control until the end of the study;
6. Be able to read, understand and give written informed consent;
7. Be willing to comply with intensive diabetes management.
Minimum age
10 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of immunosuppressive or immunomodulatory therapies other than inhaled or topical glucocorticoids;
2. Current or past history of deep vein thrombosis or pulmonary embolism;
3. Impaired renal function defined by estimated glomerular filtration rate (according to the CKD-EPI) of < 60 mL/min/1.73 m2;
4. LDL cholesterol >4mmol/l;
5. Elevated liver function tests at screening:

1. Aspartate aminotransferase 2x ULN
2. Alanine aminotransferase 2 x ULN;
6. Clinically significant abnormal laboratory parameters at screening including but not limited to:

1. Hemoglobin < 8 g/L;
2. White blood cells <2500 cells/µl;
3. Lymphocyte count <750 cells/µl;
4. Platelets <50,000 cells/µl;
5. Neutrophils <1200cells/µL;
7. Known hypersensitivity to baricitinib;
8. Known malignancy with the exception of successfully treated non- metastatic basal cell and squamous cell carcinoma;
9. Pregnancy, a desire for pregnancy, breast feeding, or a desire to father a child during the study;
10. Patients with current or recent (within 12 weeks of screening) clinically significant comorbidity, including clinically serious viral, bacterial, fungal, or parasitic infection. Viral infections include HBV, HCV, EBV, HIV, recent herpes zoster and TB;
11. Treatment with any investigational product within 30 days or 5 half - lives (whichever is longer) prior to baseline visit, or concurrent participation in a clinical trial with an investigational product or device;
12. Experienced any of the following within 12 weeks of screening: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure;
13. Any serious medical condition within the previous 4 weeks which places the participant at an unacceptable risk if he or she were to participate in the study or confounds the ability to interpret data from the study, including, but not limited to, symptomatic cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine, haematological and neurological conditions or psychiatric illness/social situations that would limit compliance with study requirements;
14. Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study that, in the opinion of the investigator would pose an unacceptable risk to the participant;
15. History of chronic alcohol abuse or IV drug abuse or other illicit drug abuse within 2 years prior to screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/05/2024
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Women's and Children's Hospital Adelaide - North Adelaide
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [4] 0 0
Royal Children's Hospital Melbourne - Parkville
Recruitment postcode(s) [1] 0 0
5006 - North Adelaide
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Institute of Medical Research
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Juvenile Diabetes Research Foundation Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Juvenile Diabetes Research Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tom Kay, Prof
Address 0 0
SVI
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication, and for at least 15 years after the end of the study.
Available to whom?
The data will be made available on a case-by-case basis at the discretion of primary sponsor and only to researchers who have obtained ethical approval to access it.

Access is subject to approvals by the Principal Investigator, Prof Thomas Kay. Enquiries should be directed to tkay@svi.edu.au.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Waibel M, Wentworth JM, So M, Couper JJ, Cameron F... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT04774224