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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1865

Inclusion Criteria

• 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).
• 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
• Age 18 – 80 years, both inclusive (as allowed according to local guidelines for metformin and glimepiride treatment)
• BMI = 40.0 kg/m2

At randomisation:
• Daily use of 2000 mg metformin for at least three weeks
• Mean fasting plasma glucose of 7.0-12.8 millimol (mmol)/L both incl. (126-230 mg/dL both incl.)

Are the trial subjects under 18?
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

• Treatment with insulin within the last three months prior to the trial (except for short-term treatment with insulin in connection with intercurrent illness at the discretion of the Investigator).
• Impaired liver function, defined as alanine aminotransferase (ALAT) = 2.5 times upper limit of normal (ULN) (one retest analysed at the central laboratory within a week is permitted with the result from the last sample being conclusive).
• Impaired renal function defined as serum-creatinine = 135 µmol/l (= 1.5 mg/dL) for males and = 110 µmol/l (= 1.3 mg/dL) for females (one retest analysed at the central laboratory within a week is permitted with the result from the last sample being conclusive).
• 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.
• Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator.
• Recurrent major hypoglycaemia as judged by the Investigator.
• Use of any drug (except for OADs), which in the Investigator’s opinion could interfere with the glucose level (e.g. systemic corticosteroids).

• 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).