iraglutide Effect and Action in Diabetes (LEAD-2): Effect on glycaemic control after once daily administration of liraglutide in combination with metformin versus metformin monotherapy versus metformin and glimepiride combination therapy in subjects with type 2 diabetes. A six-month double-blind, double-dummy, randomised, active control, parallel-group, multi-centre, multi-national trial with an 18 months trial extension period - LEAD-2

Conditions: Type 2 Diabetes Mellitus
MedDRA version: 9.1Level: LLTClassification code 10012601Term: Diabetes mellitus

Registration Number: EUCTR2005-003417-32-IT

Lead Sponsor: OVO NORDISK

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1865

Inclusion Criteria

1. Informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject). 2. Subjects diagnosed with type 2 diabetes and treated with OAD(s) for at least three months HbA1c: 7.0-10.0 % (both incl.) in subjects on OAD combination therapy 7.0-11.0 % (both incl.) in subjects on OAD monotherapy 3. Age 18 ? 80 years, both inclusive (as allowed according to local guidelines for metformin and glimepiride treatment) 4. BMI <= 40.0 kg/m2
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 insulin within the last three months prior to trial (except for short-term treatment due to intercurrent illness at the discretion of the Investigator) 2. Impaired liver function, defined as ALAT >= 2.5 times upper limit of normal (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive). 3. Subjects known to be Hepatitis B antigen or Hepatitis C antibody positive 4. Impaired renal function defined as serum-creatinine >=135 ?mol/L (>= 1.5 mg/dL) for males and >= 110 ?mol/L ( >= 1.3 mg/dL) for females (one retest analysed at the central laboratory within a week is permitted with the result of the last sample being conclusive). 5. Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III and IV) at the discretion of the Investigator. (Please refer to Appendix C). 6. Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator. 7. Uncontrolled treated/untreated hypertension (systolic blood pressure >= 180 millimetre mmHg and/or diastolic blood pressure >= 100 mmHg). 8. Cancer (except basal cell skin cancer or sqaumous cell skin cancer) or any clinically significant disease or disorder, except for conditions associated to type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial. 9. Recurrent major hypoglycaemia as judged by the Investigator. 10. Known or suspected allergy to trial product(s) or related products. 11. Use of any drug (except for OADs), which in the Investigator's opinion could interfere with glucose levels (e.g. systemic corticosteroids). 12. Receipt of any investigational drug within the four weeks prior to this trial. 13. Previous participation in the randomised phase of this trial. Re-screening is allowed once, within the recruitment period. 14. Known or suspected abuse of alcohol or narcotics. 15. Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation. 16. Females of child bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice). 17. Any contraindications to metformin or glimepiride (according to local requirements).