Comparison of Twice-Daily Insulin Lispro Low Mixture Versus Once-Daily Basal Insulin Glargine and Once-Daily Prandial Insulin Lispro as Insulin Intensification Strategies in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Basal Insulin Glargine and Metformin and/or Pioglitazone

CompletadoFase 4ClinicalTrials.gov

ID: NCT01175824Tipo: INTERVENTIONALInicio: 1 de abr de 2011Fin estimado: 1 de nov de 2012

Traducción no disponible, mostrando original

Resumen

The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants with Type 2 Diabetes.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Present with type 2 diabetes mellitus
Have been taking metformin and/or pioglitazone
Have received treatment with basal insulin glargine, injected once a day, for greater than or equal to 90 days
Have glycosylated hemoglobin A1c (HbA1c) concentration between greater than or equal to 7.5% and less than or equal to 10.5
Have a fasting plasma glucose concentration of less than or equal to 6.7 millimoles per liter \[mmol/L, less than or equal to 121 milligrams per deciliter (mg/dL)\], or greater than 6.7 mmol/L (greater than 121 mg/dL) if the investigator considers that further titration of basal insulin glargine is not possible for safety reasons
Not pregnant or breastfeeding

Criterios de exclusión

Have Type 1 Diabetes
Their stable dose of pioglitazone is greater than the maximum dose approved for use in combination with insulin in their country
Have a body mass index (BMI) greater than 45 kilograms per square meter (kg/m2).
Have a history of scheduled mealtime (prandial) insulin use within 12 weeks of the screening visit and the total duration of the prandial insulin treatment was greater than 2 weeks
Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study
Have cardiac disease with a functional status that is Class III or IV
Have a history of renal or liver disease
Have had a blood transfusion or have a blood disorder

Intervenciones

drug

Insulin Lispro Low Mixture (LM)

Participant-dependent dose, administered subcutaneously for 24 weeks

drug

Insulin Glargine

Participant-dependent dose, administered subcutaneously for 24 weeks

drug

Prandial Insulin Lispro

Participant-dependent dose, administered subcutaneously for 24 weeks

Ubicaciones

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mar del Plata, Argentina

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ramos Mejía, Argentina

Patrocinadores

PrincipalEli Lilly and Company

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

Comparison of Twice-Daily Insulin Lispro Low Mixture Vers... | EligiMed