Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes.
- Conditions
- Diabetes type 110018424
- Registration Number
- NL-OMON43891
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline in HbA1c 16 weeks after randomisation. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The confirmatory secondary endpoints are:<br /><br>* Change from baseline in 1-hour PPG increment 16 weeks after randomisation<br /><br>(meal test)<br /><br>* Change from baseline in 1,5 anhydroglucitol 16 weeks after randomisation<br /><br>* Change from baseline of time spent in low IG (*3.9 mmol/L [70 mg/dL]) during<br /><br>CGM 16 weeks after randomisation.</p><br>