NL-OMON43891
Completed
Phase 3
Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes. - onset® 5
ovo Nordisk0 sites35 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Diabetes type 1
- Sponsor
- ovo Nordisk
- Enrollment
- 35
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, age \* 18 years, at the time of signing informed consent
- •Type 1 diabetes mellitus \* 1 year prior to the day of screening
- •Using the same Medtronic pump (Minimed 530G, Paradigm Veo, Paradigm Revel, Paradigm) with CSII(continuous subcutaneous insulin infusion) in a basal\-bolus regimen for at least 6 months prior to screening and willing to stay on the same pump throughout the trial
- •HbA1c 7\.0\-9\.0%, as assessed by central laboratory at screening
- •BMI\*35\.0 kg/m2 at screening
- •Ability and willigness to take at least 3 daily meal\-time insulin bolus infusions every day througout the trial.
Exclusion Criteria
- •Any of the following; myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •History of hospitalisation for ketoacidosis \*180 days prior to the day of screening
- •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
- •Any condition which, in the opinion of the Investigator. might jeopardise a Subject's safety or compliance with the protocol.
Outcomes
Primary Outcomes
Not specified
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