Efficacy and Safety of Continuous Subcutaneous Insulin Infusion of Faster-acting Insulin Aspart compared to NovoRapid® in Adults with Type 1 Diabetes
- Conditions
- Diabetes Mellitus, Type 1MedDRA version: 19.0Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2010-024054-11-SI
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 506
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
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
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the effect of continuous subcutaneous insulin infusion (CSII) treatment with faster-acting insulin aspart in terms of glycaemic control by comparing it to CSII treatment with NovoRapid®, in adults with Type 1 Diabetes Mellitus (T1DM), using a non-inferiority approach;Secondary Objective: To confirm superiority of CSII treatment with faster-acting insulin aspart compared to CSII treatment with NovoRapid® in adults with T1DM, in terms of:<br><br>- Postprandial glucose (PPG) regulation (meal test)<br>- Overall glycaemic control (HbA1c)<br>- Postprandial glucose excursions (1,5-anhydroglucitol)<br>- Time spent in low interstitial glucose (IG) (Continuous Glucose Monitoring (CGM))<br><br>To compare the effect and safety of CSII treatment with faster-acting insulin aspart vs CSII treatment with NovoRapid® in adults with T1DM;Primary end point(s): Change from baseline in glycosylated haemoglobin (HbA1c) ;Timepoint(s) of evaluation of this end point: 16 weeks after randomisation
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change from baseline in 1-hour PPG increment (meal test)<br>2. Change from baseline in 1,5-anhydroglucitol<br>3. Change from baseline of time spent in low IG (=3.9 mmol/L [70 mg/dL]) during CGM ;Timepoint(s) of evaluation of this end point: 1. + 2. + 3.: 16 weeks after randomisation