A 52-week randomised, controlled, open label, multicentre, multinational treat-to-target trial comparing efficacy and safety of SIBA and insulin glargine both administered once daily in a basal-bolus regimen with insulin aspart as mealtime insulin ± treatment with metformin, ± pioglitazone in subjects with type 2 diabetes currently treated with insulin qualifying for intensified treatment. - ND

Active, not recruiting

Conditions: subjects with type 2 diabetes currently treated with insulin qualifying for intensified treatment
MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

Registration Number: EUCTR2008-005777-35-IT

Lead Sponsor: OVO NORDISK

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 1403

Inclusion Criteria

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) Males or females, age ≥ 18 years Type 2 diabetes mellitus (diagnosed clinically) ≥ 6 months 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 HbA1c 7.0 ? 10.0% (both inclusive) by central laboratory analysis BMI ≤ 40.0 kg/m^2 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

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.Off-label use of any concomitant medication, including OADs to be continued in the trial. 4.For pioglitazone users: 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 nfarction; 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