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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes, Diabetes Mellitus, Type 1

In brief

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.

Key facts

Study ID

NCT02443155

Run by

Novo Nordisk A/S

People needed

308

Starts

2015-11-10

Expected to finish

2019-02-27

Last updated by the study team

2021-04-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Northridge, California, United States
• Novo Nordisk Investigational Site — Aurora, Colorado, United States
• Novo Nordisk Investigational Site — Miami, Florida, United States
• Novo Nordisk Investigational Site — Orlando, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Las Vegas, Nevada, United States
• Novo Nordisk Investigational Site — Teaneck, New Jersey, United States
• Novo Nordisk Investigational Site — Chapel Hill, North Carolina, United States
• Novo Nordisk Investigational Site — Nashville, Tennessee, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Mesquite, Texas, United States
• Novo Nordisk Investigational Site — Graz, Austria
• Novo Nordisk Investigational Site — Innsbruck, Austria
• Novo Nordisk Investigational Site — Salzburg, Austria
• Novo Nordisk Investigational Site — Vienna, Austria
• Novo Nordisk Investigational Site — Vienna, Austria
• Novo Nordisk Investigational Site — Brussels, Belgium
• Novo Nordisk Investigational Site — Edegem, Belgium
• Novo Nordisk Investigational Site — Leuven, Belgium
• Novo Nordisk Investigational Site — Edmonton, Alberta, Canada
• Novo Nordisk Investigational Site — Vancouver, British Columbia, Canada
• Novo Nordisk Investigational Site — Winnipeg, Manitoba, Canada
• Novo Nordisk Investigational Site — Halifax, Nova Scotia, Canada
• Novo Nordisk Investigational Site — La Jolla, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.