EUCTR2015-001047-36-ATActive, not recruitingPhase 1
Efficacy and Safety of Faster-acting Insulin Aspart compared to NovoRapid® both in combination with Insulin Degludec in Adults with Type 1 Diabetes - onset®8
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovo Nordisk A/S
- Enrollment
- 999
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 (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:
- •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)
Investigators
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