type 1 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. (Trial related activities are defined as any procedure that would not have been performed during standard management of the subject). 2. Males or females, = 18 years of age. 3. Type 1 diabetes mellitus (diagnosed clinically) = 12 months 4. Current treatment with any basal bolus insulin regimen for at least 12 months prior to Visit 1 5. HbA1c = 10.0 % by central laboratory analysis 6. BMI = 35.0 kg/m2 7. Ability and willingness to adhere to the protocol including performance of self measured plasma glucose (SMPG) profiles 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: 1. Use within the last 3 months prior to Visit 1 of any other antidiabetic glucose lowering drug than insulin 2. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors 3. Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA)2 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty. 4. Uncontrolled treated/untreated severe hypertension (systolic blood pressure = 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure = 100 mmHg) 5. Impaired liver function, defined as ALAT = 2.5 times upper limit of normal (one re-test analysed at the central laboratory within a week from receipt of the result is permitted with the result of the last sample being conclusive). 6. Impaired renal function defined as serum creatinine = 180 µmol/L (= 2.0 mg/dL); one re-test within a week from receipt of the result is permitted. Last sample will be conclusive 7. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness or hospitalisation for diabetic ketoacidosis during the previous 6 months 8. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator 9. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements (for Germany: implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner)(for UK: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system, or consistent use of barrier methods). 10. Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer) 11. Any clinically significant disease or disorder, except for conditions associated with type 1 diabetes, which in the Investigator’s opinion could interfere with the results of the trial 12. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write 13. 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. 14. Known or suspected allergy to any of the trial products or related products 15. Receipt of any investigational drug within one month prior to screening visit (Visit 1) 16. Donation of blood or participation in other trials within one month prior to screening visit (Visit 1) 17. Known or suspected abuse of alcohol, narcotics or illicit drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the efficacy of SIBA + insulin aspart in controlling glycaemia with respect to change from baseline in HbA1c after 52 weeks of treatment. This is done by comparing the difference in change from baseline in HbA1c after 52 weeks of treatment between SIBA + insulin aspart and insulin glargine + insulin aspart to a non-inferiority 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 glargine + insulin aspart after 52 week of treatment in terms of: • Nocturnal hypoglycaemic episodes • Hypoglycaemic episodes • Fasting plasma glucose (FPG) from central laboratory • Within-subject variability in self-measured pre-breakfast plasma glucose (PG) 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 • Insulin antibodies • Patient reported outcome (PRO);Primary end point(s): Change from baseline in HbA1C after 52 weeks of treatment (analysed by central laboratory). | — |
Countries
France, Germany, United Kingdom
Outcome results
None listed