type 2 diabetes MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II 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. Male or female, age = 18 years 3. Type 2 diabetes mellitus (diagnosed clinically) = 6 months 4. Current treatment with any insulin regimen (premix, self-mix, basal only, basal bolus (one or more boluses), bolus only, pump) for at least 3 months +/- OADs prior to Visit 1 5. HbA1c 7.0 – 10.0% (both inclusive) by central laboratory analysis 6. BMI = 40.0 kg/m2 7. Ability and willingness to adhere to the protocol including performance of 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: GLP-1 receptor agonist (exenatide, liraglutide) and/or rosiglitazone 2. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors 3. Contraindications or restrictions (according to approved labelling or local practice) to use of the concomitant anti-diabetic medication allowed in the trial (in the last 3 Months prior to randomization) 4. For pioglitazone user: clinically significant peripheral oedema or contraindications/restrictions to pioglitazone use 5. Cardiovascular disease, within the last 6 months prior to visit 1, defined as: stroke; decompensated heart failure New York Heart Association (NYHA)29 class III or IV; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty. 6. Uncontrolled treated/untreated severe hypertension (systolic blood pressure = 180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure = 100 mmHg) 7. Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the result is permitted with the result of the last sample being conclusive)8. Impaired renal function defined as serum-creatinine = 125 µmol/L (= 1.4 mg/dL) for males and = 110 µmol/L (= 1.3 mg/dL) for females or according to local label for metformin use. One retest within a week of receipt of the result is permitted with the result of the last sample being conclusive 9. Recurrent (more than 1 severe hypoglycaemic event per year) severe hypoglycaemia or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months 10. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator 11. 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 intrauterine device (IUD), sexual abstinence or vasectomised partner) 12. Cancer and any medical history of cancer (except basal cell skin cancer or squamous cell skin cancer) 13. Any clinically significant disease or disorder, except for conditions associated with type 2 diabetes, which in the Investigator’s opinion could interfere with the results of the trial 14. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subject not able to read or write 15. Previous participation in this trial. Participation is defined as randomised. Re-screening for screening failures is allowed once only within the limits of the recruitment period 16. Known or suspected allergy to any of the trial products or related products 17. Receipt of any investigational drug within one month prior to Visit 1 18. Donation of blood or participation in other trials within one month prior to Visit 1 19. 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 ± OAD(s) 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 ± OAD(s) and insulin glargine + insulin aspart ± OAD(s) 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 ± OAD(s) to insulin glargine + insulin aspart ± OAD(s) after 52 weeks of treatment in terms of: • Hypoglycaemic episodes • FPG from central laboratory • Within-subject variability in self-measured FPG • Frequency of responders for HbA1c without hypoglycaemic episodes To compare efficacy and safety in terms of: • Frequency of responders for HbA1c • 9-point profile (SMPG) • Insulin dose • Body weight • AEs • Hypoglycaemic episodes • Clinical and laboratory assessments • Cardiovascular risk markers • PRO;Primary end point(s): Change from baseline in HbA1c after 52 weeks of treatment (analysed by central laboratory). | — |
Countries
Bulgaria, Germany, Ireland, Italy, Spain
Outcome results
None listed