A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: NNC0114-0006; liraglutide; placebo
Intervention description: NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment; Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment; Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 308.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      This trial is conducted globally. The aim of this trial is to assess the clinical
      proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in
      adult subjects with newly diagnosed type 1 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent obtained before any trial-related activities. Trial-related
             activities are any procedures that are carried out as part of the trial, including
             activities to determine suitability for the trial

          -  T1DM (type 1 diabetes mellitus) (as diagnosed clinically) for not more than 20 weeks
             prior to screening - Male or female, aged 18-45 (both inclusive) at the time of
             signing the informed consent form

          -  Non-fasting peak C-peptide higher or equal to 0.2 nmol/l at visit 2

          -  BMI (body mass index) higher or equal to 18.5 kg/m^2

          -  Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase
             (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening

          -  Insulin dependence unless in temporary spontaneous remission (honeymoon period)

        Exclusion Criteria:

          -  Daily insulin usage above 1 U/kg per day at screening or use of continuous
             subcutaneous insulin infusion (CSII)

          -  History of recurrent (e.g. several times a year) of severe (e.g. pneumonia) or chronic
             infections or conditions predisposing to chronic infections (e.g., bronchiectasis and
             chronic osteomyelitis)

          -  History of severe systemic fungal infection within the past 12 months prior to
             screening unless treated and resolved with appropriate documented therapy

          -  Vaccination within 4 weeks before randomisation, Visit 3 (V3)

          -  Receipt of any other concomitant medications or herbal products that can influence the
             immune system within 90 days prior to screening (V1)

          -  History of pancreatitis (acute or chronic)

          -  Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary
             Thyroid Carcinoma (MTC)

          -  Any past or current diagnosis of malignant neoplasms

          -  Known impairment of the immune system, except for T1DM, coeliac disease, alopecia,
             autoimmune antibodies not considered clinical important (e.g. thyroid antibodies
             without any clinically important thyroid disease), and vitiligo