A 26 week randomised, controlled, open label, multicentre, multinational, three-arm, treat to target trial comparing efficacy and safety of three different dosing regimens of either Soluble Insulin Basal Analogue (SIBA) or insulin glargine with or without combination with OAD treatment, in subjects with type 2 diabetes mellitus

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

Registration Number: EUCTR2008-005771-10-FI

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 965

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. Current treatment: OAD(s) alone, basal insulin alone or the combination of OAD(s) and basal insulin. Allowed OADs (alone or in combination with basal insulin) are: Metformin, insulin secretagogues (sulphonylureas (SU) or glinides), pioglitazone with unchanged dosing for at least 3 months prior to Visit 1 with the minimum doses stated:
a. Metformin: alone or in combination (including fixed combination) 1500 mg daily, or maximum tolerated dose (at least 1000 mg daily)
b. Insulin secretagogue (sulfonylurea or glinide): Minimum half of the daily maximal dose according to local labelling
c. Pioglitazone: Minimum half of the daily maximal dose according to local labelling or maximum tolerated dose
5. HbA1c: OADs only users 7.0-11.0 % (both inclusive), basal insulin ± OADs users 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

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), rosiglitazone, DPP-IV inhibitors, a-glucosidase-inhibitors
2. Anticipated change in concomitant medication known to interfere significantly with glucose metabolism, such as systemic corticosteroids, beta-blockers, MAO inhibitors
3. Local off-label use of any concomitant medication, including OADs to be continued in the trial
4. 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.
5. Uncontrolled treated/untreated severe hypertension (systolic blood pressure =180 millimetre (mm) mercury (Hg) and/or diastolic blood pressure = 100 mmHg).
6. 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 result is permitted with the result of the last sample being conclusive).
7. 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 re-test within a week of receipt of the result is permitted with the result of the last sample being conclusive.
8. Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during last 12 months) or hypoglycaemic unawareness as judged by the Investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months
9. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
10. Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements
11. Cancer and medical history of cancer hereof (except basal cell skin cancer and squamous cell skin cancer)
12. 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
13. Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read or write
14. 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.
15. Known or suspected allergy to any of the trial products or related products
16. Receipt of any investigational drug within one month prior to Visit 1.
17. Donation of blood or participation in other trials within one month prior to Visit 1
18. Known or suspected abuse of alcohol, narcotics or illicit drugs