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

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