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? 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

• 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 childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal IUD, sexual abstinence or vasectomised partner).
•Subjects with medical history of MEN2 or FMTC if total thyroidectomy has not been performed or cannot be ensured (i.e. posterior capsule of the thyroid gland not removed).