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 normal management of the subject) 2. Male or female = 18 years of age 3. Type 1 diabetes mellitus (diagnosed clinically) for = 12 months 4. Ongoing daily treatment with insulin (in a basal bolus regimen, premix insulin regimen, self mix regimen) for at least 12 months prior to Visit 1 5. HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis 6. BMI =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Treatment with other insulin regimens than those listed in inclusion criterion No. 4 within 3 months prior to Visit 1 2. Basal-bolus regimen with basal insulin injected BID 3. Use within the last 3 months prior to Visit 1 of any other antidiabetic glucose lowering drug than insulin 4. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, monoamine oxidase (MAO) inhibitors 5. Anticipated significant lifestyle changes during the trial, shift work (including permanent night/evening shift workers), as well as highly variable eating habits 6. 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 7. Uncontrolled treated/untreated severe hypertension (systolic blood pressure =180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure = 100 mmHg) 8. Impaired liver function, defined as ALAT = 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week of receipt of the results is permitted with the result of the last sample being conclusive) 9. Impaired renal function defined as serum-creatinine =180 µmol/l (= 2 mg/dl ). One retest analysed at the central laboratory within a week of receipt of the results is permitted with the result of the last sample being conclusive 10. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months 11. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator 12. 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 United Kingdom (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) 13. Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer) 14. Any clinically significant disease or disorder, which in the Investigator’s opinion could interfere with the results of the trial 15. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subject not able to read or write 16. 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. 17. Known or suspected allergy to any of the trial products or related products 18. Receipt of any investigational drug within one month prior Visit 1 19. Donation of blood or participation in other trials within one month prior to Visit 1. 20. Known or suspected abuse of alcohol, narcotics or illicit drugs Subjects randomised in error (not fulfilling the inclusion and/or exclusion criteria) must be withdrawn immediately from the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm efficacy of SIAC once daily (OD) + meal-time insulin aspart for the remaining meals 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 SIAC OD + meal-time insulin aspart for the remaining meals and insulin detemir + 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: To confirm superiority of SIAC OD + meal-time insulin aspart for remaining meals over insulin detemir + meal-time insulin aspart after 26 week of treatment in terms of: • Fasting plasma glucose (FPG) measured at a central laboratory • Frequency of responders for HbA1c without hypoglycaemic episodes • Nocturnal hypoglycaemic episodes To compare efficacy and safety after 26 weeks of treatment in terms of: • 9-point profile, self measured plasma glucose (SMPG) • Self measured plasma glucose for dose adjustments • Frequency of responders for HbA1c • Adverse events • Hypoglycaemic episodes • Clinical and laboratory assessments • Insulin antibodies • Body weight • Insulin dose • Patient reported outcome;Primary end point(s): Change from baseline in HbA1c after 26 weeks of treatment (analysed by central laboratory) | — |
Countries
Denmark, France, United Kingdom
Outcome results
None listed