Type 1 diabetes MedDRA version: 12.0 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Type 1 diabetes (diagnosed clinically and treated on basal-bolus regimen) for = 12 months, hereof the last 3 months with injection based therapies • Current treatment with any basal insulin (e.g. insulin glargine, insulin detemir, NPH insulin) using one or two daily injections and with three or more daily meal-time insulin injections (e.g. insulin aspart, insulin lispro, insulin glulisine, human insulin)used as bolus insulin therapy • HbA1c = 10.0 % by central laboratory analysis • BMI = 35.0 kg/m2 • Ability to self-manage insulin therapy as assessed by confirmation (verbal confirmation at screening visit) of a changed insulin dose in the preceding two months prior to screening. • Ability and willingness to adhere to the protocol including performance of SMPG profiles and self-adjustment of insulin doses according to the protocol 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 antidiabetic glucose lowering drug other than insulin • Initiation or significant change of any systemic treatment which, in the Investigator’s opinion, could interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers or MAO inhibitors (inhaled corticosteroids are allowed) • 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 event during last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months • Proliferative retinopathy or maculopathy requiring treatment according to the Investigator • 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 • Known or suspected allergy to any of the trial products or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to confirm the efficacy of NN1250 administered once daily in a fixed flexible schedule in combination with meal-time 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 NN1250 administered in this fixed flexible regimen in combination with meal-time insulin aspart and insulin glargine administered once daily according to approved labelling in combination with meal time insulin aspart to a non-inferiority limit of 0.4%, and if non-inferiority is confirmed, to a superiority limit of 0%.;Secondary Objective: - The efficacy of NN1250 administered once daily in the fixed flexible schedule in combination with meal-time insulin aspart will be compared to the efficacy of NN1250 administered once daily with the main evening meal in combination with meal-time insulin aspart, in terms of change from baseline HbA1c. - The efficacy and safety after 26 weeks of treatment between the three treatment groups will be assessed and compared in terms of: • Frequency of responders for HbA1c • Fasting plasma glucose (FPG) from central laboratory • 9-point self measured plasma glucose (SMPG) profile • 4-point (SMPG) profile for dose adjustments • Adverse events (AEs) • Body weight • Hypoglycaemic episodes • Clinical and laboratory assessments • Insulin antibodies • Basal and bolus insulin dose - The long-term safety and tolerability after 2 times 26 weeks of treatment with NN1250 will be investigated by comparing the NN1250 arms to glargine, both in combination with insulin aspart.;Primary end point(s): Key efficacy endpoints: • Change from baseline in HbA1c after 26 weeks of treatment • Change from baseline in FPG after 26 weeks of treatment Key safety endpoints: • Severe and minor hypoglycaemic episodes • Treatment emergent AEs (TEAEs) • Basal and bolus insulin doses | — |
Countries
Belgium, Germany, Norway, United Kingdom
Outcome results
None listed