Type 1 diabetes
Conditions
Interventions
Trade Name: Taltz
Pharmaceutical Form: Suspension for injection in pre-filled injector
Pharmaceutical form of the placebo: Suspension for injection in pre-filled injector
Route of administration of t
Sponsors
Göteborgs Universitet
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for inclusion in the study have to fulfil all of the following criteria: • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations before trial activities are begun. • Must be willing and capable of taking the study drugs and meet for tests and follow up as described. • Diagnosed Type 1 Diabetes (E10.9) within 100 days. • First injection of insulin maximum 100 days prior to screening. If age 36-45 years, a current insulin regimen of both basal and prandial insulin or alternately use of an insulin pump should exist. • Aged 18-45 years old. • Presence of antibodies at clinical practice or at screening to at least one of the following antigens: insulin/IAA, GAD-65, IA-2 and ZnT8. • Remaining stimulated peak C–peptide = 0.20 nmol/L. If age 36-45 years, peak C-peptide should be =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects fulfilling any of the following criteria are not eligible for inclusion in this study: • Contraindications to Ixekizumab. • Treatment with any oral or injected glucose-lowering agents other than insulin. • A history of haemolytic anaemia or significantly abnormal haematology/coagulation results at screening. • Participation in other clinical trials with a new chemical entity within the previous 3 months. • Subjects with severe obesity (BMI >35 kg/m2 if age 18-35 years and BMI >30 kg/m2 if age 36-45), psoriasis, psoriasis arthritis and axial spondylarthrosis, except celiac disease and hypothyroidism which do not need to be excluded for. • Active serious or chronic infections (ie: in case patient had a serious infection (eg pneumonia, cellulitis), has been hospitalized, has received intravenous antibiotics for an infection within 12 weeks prior to screening visit, had a serious bone or joint infection within 24 weeks before screening visit, has ever had an infection of an artificial joint • Known immunodeficiency or patient is immunocompromised to an extent that participation in the study would pose and unacceptable risk to the patient • Active or latent tuberculosis • HIV or active hepatitis B or C • Active or recurrent fungal infection • Subjects with myocardial infarction, stroke, unstable angina or heart failure last 6 months • Current clinically significant cardiac arrhythmias as verified by ECG • Planned surgery during the treatment period of the study (except minor surgery on skin lesions, e.g., nevus) • For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 3- months after discontinuation. • For male subjects: intent to procreate during the duration of the study or within 3 months after discontinuation or unwillingness of their partner to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. • Any history of malignancy the last 5 years except for completely resected squamous or basal cell carcinoma of the skin. • Administration of live attenuated vaccine(s) (LAV) within 2 months of enrolment. Or intended use of LAV during the treatment period. • The investigator judges that the clinical diagnosis of T1D set is incorrect or uncertain (needs to be confirmed by discussion with experienced diabetologist if excluding due to this criterion) • Allergy against ingredients of the investigational products. • Known allergy or hypersensitivity to any biologic therapy (active substance or excipients) that would pose an unacceptable risk to the patient if participating in the study • Presence of serious disease or condition, which in the opinion of the investigator makes the patient non-eligible for the study. • Liver injury criteria: patients with active hepatobiliary diseases or at screening having alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 times the upper limit of normal (>2.5 x ULN) • Laboratory abnormalities at screening: a. Neutrophil count < 1,500 cells/ µL (=1,5 *109 cells/ L) b. Platelet count < 100,000 cells/ µL (= 100 *109 cells/ L) c. Hemoglobin < 8.5 g/dL (= <85 g/L) (males) and <8g/dL (= <80 g/L) (women)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to examine whether Ixekizumab compared with placebo increases residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile (Mixed Meal Tolerance Test) in newly diagnosed patients with type 1 diabetes.;Secondary Objective: Secondary objectives are to examine whether treatment with Ixekizumab compared with placebo leads to change in: • Mean Insulin dosage per kilo body weight • Time in range (3.9-10 mmol/l) measured by masked CGM • Time in hypoglycaemia (<3.9 mmol/l) measured by masked CGM • Difference in HbA1c ;Primary end point(s): The primary endpoint is change in residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile measured by Mixed Meal Tolerance Test (MMTT) between baseline and week 52.;Timepoint(s) of evaluation of this end point: The primary efficacy variable is difference in change in residual insulin secretion measured by stimulated C-peptide two-hour area under the curve profile measured by Mixed Meal Tolerance Test (MMTT) from baseline to week 52 between the two treatment groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are the following: • Change in mean Insulin dosage per kilo bodyweight for 24 hours from baseline to week 52. • Change in time with glucose levels in range (3.9-10 mmol/l) measured by masked CGM (Libre Pro) from baseline to week 52 • Change in time of hypoglycaemia (<3.9 mmol/l) measured by masked CGM (Libre Pro) from baseline to week 52 • Difference in HbA1c from baseline to week 52 ;Timepoint(s) of evaluation of this end point: The secondary efficacy variables are: • Difference in change in mean Insulin dosage per kilo bodyweight for 24 hours from baseline to week 52 between the two treatment groups. • Difference in change in time in range (3.9-10 mmol/l) from baseline to week 52 measured by masked CGM (Libre Pro) between the two treatment groups. • Difference in change in time in hypoglycaemia (<3.9 mmol/l) from baseline to week 52 measured by masked CGM (Libre Pro) between the two treatment groups. • Difference in HbA1c from baseline to week 52 between the two treatment groups. | — |
Countries
Sweden
Contacts
Public ContactNU Hospital Group
Västra Götalandsregionen, NU Hospital Group
Outcome results
None listed