The Effect of Liraglutide Versus Placebo When Added to Basal Insulin Analogues With or Without Metformin in Subjects With Type 2 Diabetes

CompletadoFase 3ClinicalTrials.gov

ID: NCT01617434Tipo: INTERVENTIONALInicio: 1 de sept de 2012Fin estimado: 1 de oct de 2013

Traducción no disponible, mostrando original

Resumen

This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

HbA1c (glycosylated haemoglobin A1c) 7.0-10.0% (both inclusive)
Body mass index (BMI) 20-45 kg/m\^2 (both inclusive)
Diagnosed with type 2 diabetes for at least 180 days prior to screening and treated with stable basal insulin analogue dose of minimum 20 U/day with or without stable metformin equal to or above 1500 mg/day for at least 8 weeks prior to screening (defined as insulin adjustments less than 10% during the past 8 weeks as assessed by the investigator)
Impaired liver or renal function
Uncontrolled treated or untreated hypertension (systolic blood pressure (SBP) equal to or above 180 mmHg and/or diastolic blood pressure (DBP) equal to or above 100 mmHg)
Any clinically significant disorder, except for conditions associated with type 2 diabetes history which in the investigator's opinion could interfere with results of the trial
Known or suspected abuse of alcohol or narcotics

Criterios de exclusión

Female of child-bearing potential who is pregnant, breast-feeding or intending to become pregnant
Recurrent severe hypoglycaemic episodes or hypoglycaemic unawareness

Intervenciones

drug

liraglutide

Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

drug

placebo

Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Ubicaciones

Novo Nordisk Investigational Site

Buenos Aires, Argentina

Novo Nordisk Investigational Site

Caba, Argentina

Novo Nordisk Investigational Site

Caba, Argentina

Novo Nordisk Investigational Site

Córdoba, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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