Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in combination with Insulin Degludec in Adults with Type 1 Diabetes

Phase 1

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

• Registration Number: EUCTR2015-001047-36-IT
• Lead Sponsor: OVO NORDISK. S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-16
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 999

Inclusion Criteria

1. Male or female, age = 18 years (for Japan and Taiwan: age =20 years) at the time of signing informed consent
2. Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) =12 months prior to screening
3. Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1)
4. Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1)
5. HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory
6. Body Mass Index = 35.0 kg/m^2
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 900
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 99

Exclusion Criteria

1. Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack
2. Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation
3. Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1)
4. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)

Study & Design

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