A 26-week, multinational, multi-centre, open-labelled, two-arm, parallel, randomised, treat-to-target trial comparing efficacy and safety of soluble insulin analogue combination (SIAC) once daily plus meal-time insulin aspart for the remaining meals vs. basal-bolus treatment with insulin detemir plus meal-time insulin aspart in subjects with type 1 diabetes

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

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 < 35.0 kg/m²
7. Ability and willingness to adhere to the protocol including performance of SMPG profiles according to the protocol
8. Subject is likely to comply with the Investigators instruction.
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. 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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