Comparación Aleatoria y Controlada con Placebo de los Efe... | EligiMed

Comparación Aleatoria y Controlada con Placebo de los Efectos de Dos Dosis de LY2189265 o Exenatide sobre el Control Glucémico en Pacientes con Diabetes Tipo 2 en Dosis Estables de Metformin y Pioglitazona (AWARD-1: Evaluación de la Administración Semanal de LY2189265 en Diabetes-1)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01064687Tipo: INTERVENTIONALInicio: 1 de feb de 2010Fin estimado: 1 de may de 2012

Resumen

El propósito de este estudio es determinar si LY2189265 es eficaz y seguro para reducir la hemoglobina A1c (HbA1c), en comparación con el placebo (sin medicamento) o con exenatide, en participantes con Diabetes Tipo 2. Los participantes también deben estar tomando metformin y pioglitazona.

Descripción detallada

Durante el estudio, si un participante desarrollaba hiperglucemia grave y persistente a pesar del cumplimiento total del régimen terapéutico asignado, recibía una intervención terapéutica adicional o el inicio de un medicamento antihiperglucémico alternativo tras la discontinuación del fármaco del estudio (terapia de rescate). Los participantes que recibieron terapia de rescate fueron incluidos en la población de análisis, pero solo las mediciones obtenidas antes del inicio de la terapia de rescate fueron incluidas en los análisis especificados.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications
Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day.
Willing to inject subcutaneous (SC) medication up to 2 times per day
Stable weight for 3 months prior to screening
Body mass index (BMI) between 23 and 45 kilograms per meter squared (kg/m\^2)
Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.

Criterios de exclusión

Type 1 Diabetes
HbA1c equal to or less than 6.5 before randomization or at randomization
Chronic insulin use
Taking drugs to promote weight loss by prescription or over the counter
Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
History of fluid retention or edema
History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening
Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal
Acute or chronic pancreatitis of any form
Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatine clearance of less than 60 milliliters per minute (mL/min)
History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
A serum calcitonin greater than or equal to 20 picograms per milliliter (pg/mL) at screening
Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
Organ transplant except cornea
Have enrolled in another clinical trial within the last 30 days
Have previously signed an informed consent or participated in a LY2189265 (dulaglutide) study
Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening

Intervenciones

drug

LY2189265

drug

Exenatide

drug

Placebo

drug

Metformin

drug

Pioglitazone

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.

Buenos Aires, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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