ACTRN12620000239965
Active, not recruiting
Phase 2
A Phase 2, Randomised, Placebo Controlled Study Investigating the Efficacy of Baricitinib in New Onset Type 1 Diabetes Mellitus
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- St Vincent’s Institute of Medical Research
- Enrollment
- 91
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be eligible for study entry, participants must satisfy all of the following 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.
Exclusion Criteria
- •Participants will be excluded from the study if one or more of the following criteria are applicable:
- •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:
- •a.Aspartate aminotransferase 2x ULN
- •b.Alanine aminotransferase 2 x ULN;
- •6\.Clinically significant abnormal laboratory parameters at screening including but not limited to:
- •a.Hemoglobin \< 8 g/L;
Outcomes
Primary Outcomes
Not specified
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