Efecto y acción de liraglutida en diabetes (LEAD-2): Efecto sobre el control glucémico tras la administración una vez al día de liraglutida en combinación con metformina frente a metformina en monoterapia y frente a la combinación de metformina y glimepirida en sujetos con diabetes tipo 2. Ensayo de seis meses de duración, doble-ciego, doble-enmascarado, aleatorizado, activo controlado, paralelo, multicéntrico, multinacional y con un periodo de extensión de 18 meses.

ovo Nordisk A/S0 sites1,865 target enrollmentMarch 22, 2006

Overview

No summary available.

Registry

who.int

Start Date

March 22, 2006

End Date

May 4, 2007

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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
•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?

•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).