A 52 week randomised, controlled, open label, multicentre, multinational, parallel, 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 in subjects with type 1 diabetes

Conditions: type 1 diabetes
MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus

Registration Number: EUCTR2008-005774-13-DE

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 887

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

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