Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

CompletadoFase 3ClinicalTrials.gov

ID: NCT00331851Tipo: INTERVENTIONALInicio: 1 de may de 2006Fin estimado: 1 de abr de 2007

Traducción no disponible, mostrando original

Resumen

This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Type 2 diabetes
Treatment with oral anti-diabetic drugs for at least 3 months
HbA1c: 7.5-10.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy.
Body Mass Index (BMI) less than or equal to 45 kg/m2

Criterios de exclusión

Treatment with insulin within the last 3 months
Treatment with any drug that could interfere with the glucose level
Any serious medical condition
Females who are pregnant, have intention of becoming pregnant or are breastfeeding

Intervenciones

drug

liraglutide

drug

insulin glargine

drug

metformin

drug

glimepiride

Ubicaciones

Novo Nordisk Investigational Site

Bahía Blanca, Argentina

Novo Nordisk Investigational Site

Ciudad Autonoma de Bs As, Argentina

Novo Nordisk Investigational Site

Junín, Argentina

Novo Nordisk Investigational Site

Mendoza, Argentina

Novo Nordisk Investigational Site

Rosario, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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