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

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