EUCTR2010-024054-11-BEActive, not recruitingPhase 1
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes - onset® 5
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 506
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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