A trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of NNC0114-0006 and liraglutide on preservation of beta-cell functio

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 20.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-001215-39-DK
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 304

Inclusion Criteria

1. 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
2. T1DM (as diagnosed clinically*) = 20 weeks prior to screening
3. Male or female, aged 18-45 (both inclusive) at the time of signing the informed consent form
4. Non-fasting peak C-peptide =0.2 nmol/l during MMTT at Visit 2
5. BMI =18.5 kg/m^2
6. Presence of one or more islet specific auto antibodies (glutamic acid decarboxylase (GAD), islet antigen-2 (IA2) or zinc-transporter 8 (ZnT8)) at screening
7. Insulin dependence unless in temporary spontaneous remission (honeymoon period).
*The clinical diagnosis of T1DM is defined as by the following two paragraphs:
1. One or more of the following:
- HbA1c = 6.5% or
- fasting plasma glucose = 7.0 mmol/l (126 mg/dl) or
- a 2 hour plasma glucose = 11.1 mmol/l (200 mg/dl) during an oral glucose tolerance test
with a glucose load of 75 grams anhydrous glucose in water or
- classical symptoms of hyperglycaemia and a random plasma glucose = 11.1 mmol/l (200
mg/dl)
In the absence of unequivocal hyperglycaemia, results should be confirmed by repeat testing.
2. In order to:
- ensure that the aetiology is autoimmune, the clinical diagnosis needs to be confirmed by the presence of islet-specific auto-antibodies at screening
- exclude type 2 diabetes mellitus (T2DM) and latent autoimmune diabetes of adults (LADA) the subjects should be without severe insulin resistance (i.e. total daily insulin dose larger than 1 U/kg per day at screening).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 304
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Daily insulin usage > 1 U/kg per day at screening or use of continuous subcutaneous insulin infusion (CSII)
2. 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)
3. History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate documented therapy
4. Vaccination within 4 weeks before randomisation, Visit 3 (V3)
5. Receipt of any other concomitant medications or herbal products that can influence the immune system within 90 days prior to screening (V1)
6. History of pancreatitis (acute or chronic)
7. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
8. Any past or current diagnosis of malignant neoplasms
9. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified