type 1 diabetes mellitus MedDRA version: 12.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Interventions
Product Name: SIBA
Product Code: NN1250
Pharmaceutical Form: Solution for injection
Current Sponsor code: NNC0100-000-0454
Other descriptive name: Insulin 454
Concentration unit: U/ml unit(s)/millilit
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males or females, age = 18 years (= 20 years for Japan) • Type 1 diabetes mellitus (diagnosed clinically) = 12 months • Current treatment with any basal/bolus insulin regimen for at least 12 months prior to visit 1 • HbA1c = 10 % by central laboratory analysis • BMI = 35.0 kg/m² 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Use within the last 3 months prior to Visit 1 of any other antidiabetic glucose lowering drug than insulin • Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors • Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA) class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty • Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode during the last 12 months) or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months • Previous participation in this trial. Participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Change from baseline in HbA1c after 26 weeks of treatment (analysed by central laboratory).;Main Objective: To confirm the efficacy of SIBA + insulin aspart in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c after 26 weeks of treatment between SIBA + insulin aspart and insulin detemir + insulin aspart to a noninferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.;Secondary Objective: To confirm superiority of SIBA + insulin aspart to insulin detemir + insulin aspart after 26 weeks of treatment in terms of: • Nocturnal hypoglycaemic episodes (severe and minor) • Hypoglycaemic episodes (severe and minor) • Fasting plasma glucose (FPG) from central laboratory • Within-subject variability in pre-breakfast SMPG To compare efficacy and safety in terms of: • Frequency of responders for HbA1c • 9-point profile (SMPG) • 4-point profile (SMPG) for dose adjustments • Insulin dose • Body weight • Adverse events (AEs) • Hypoglycaemic episodes • Clinical and laboratory assessments | — |
Countries
Finland, Italy, United Kingdom
Outcome results
None listed