Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 19.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2010-024054-11-BE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-14
• Last Update Posted: 16 October 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 506

Inclusion Criteria

1. Male or female, age =18 years at the time of signing the informed consent
2. Diagnosed with T1DM =1 year prior to the day of screening
3. Using the same Medtronic pump (Minimed 530G (551/751), Paradigm Veo (554/754), Paradigm Revel (523/723), Paradigm (522/722)) for CSII in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.)
4. HbA1c 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening
5. Body mass index (BMI) = 35.0 kg/m^2 at screening
6. Ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial

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 405
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
3. History of hospitalization for ketoacidosis =180 days prior to the day of screening
4. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening
5. Any condition which, in the opinion of the Investigator, might jeopardise a Subject’s safety or compliance with the protocol

Study & Design

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