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

• Status: Completed
• Trial end date: 2019-02-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

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