Diabetes Mellitus, Type 1 MedDRA version: 19.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: Faster aspart 10ml Vial
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN ASPART
CAS Number: 116094-23-6
Concentration unit: U/ml unit(s)/millilitre
Concentration
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - Postprandial glucose (PPG) regulation (meal test) - Overall glycaemic control (HbA1c) - Postprandial glucose excursions (1,5-anhydroglucitol) - Time spent in low interstitial glucose (IG) (Continuous Glucose Monitoring (CGM)) 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in 1-hour PPG increment (meal test) 2. Change from baseline in 1,5-anhydroglucitol 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 | — |
Countries
Belgium, Canada, European Union, Germany, Netherlands, Russian Federation, Slovenia, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed