A 26-week, randomised, open-labelled, two-arm, parallel-group, treat-to-target trial comparing efficacy and safety of soluble insulin analogue combination (SIAC) twice daily (BID) with biphasic insulin aspart (BIAsp) 30 BID, with or without metformin, with or without DPP-4 inhibitor, with or without pioglitazone in subjects with type 2 diabetes in inadequate glycaemic control on once or twice daily premixed or self-mixed insulin regimen with or without OADs

• Conditions: type 2 diabetes; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-005768-15-FI
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06-05
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

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 = 18 years of age
3. Type 2 diabetes mellitus (diagnosed clinically) for = 6 months
4. Subject on premixed human or analogue insulin or self-mixed insulin regimen, containing 20-40 % fast/rapid-acting component, OD or BID, with or without OADs (metformin, SU, glinides, alpha-glucosidase inhibitor, DPP-4 inhibitor and pioglitazone), for at least 3 months before 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 self measured plasma glucose (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. Treatment with rosiglitazone or GLP-1 receptor agonists (exenatide, liraglutide) within 3 months prior to visit 1
3. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors
4. Off-label use of any concomitant medication, including OADs
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)2 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 range (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)
9. 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, analysed at the central laboratory within a week of receipt of the result 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
13. Cancer and medical history of cancer (except basal cell skin cancer and squamous cell skin cancer)
14. 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
15. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects 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 within one month prior to Visit 1
20. Known or suspected abuse of alcohol, narcotics or illicit drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified