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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: NNC0114-0006; Drug: liraglutide; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02443155

2014-001215-39 (EudraCT Number)

NN9828-4150

U1111-1154-7172 (Other Identifier)

REec-2015-1768 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 308 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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308 participants in 4 patient groups, including a placebo group

NNC0114-0006 + Liraglutide

Experimental group

Treatment:

Drug: liraglutide

Drug: NNC0114-0006

NNC0114-0006 + Placebo

Experimental group

Treatment:

Drug: placebo

Drug: NNC0114-0006

Liraglutide + Placebo

Active Comparator group

Treatment:

Drug: placebo

Drug: liraglutide

Placebo

Placebo Comparator group

Treatment:

Drug: placebo