The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have type 2 diabetes mellitus (T2DM) for at least 6 months
Have been treated with stable metformin dose for at least 3 months
Have HbA1c ≥7.5% and ≤11.0% at study entry
Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m\^2)

Criterios de exclusión

Have type 1 diabetes mellitus
Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)
Have been taking any other medicine for diabetes (other than metformin) during the last 3 months
Have used in the last 3 months (or plan to use) prescription weight loss medications
Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss
Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)
Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
Had chronic or acute pancreatitis any time prior to study entry
Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity
Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73m\^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator

Ubicaciones

Centro Medico CICEMO

Caba, Buenos Aires, Argentina

CEDIC-Centro de Investigaciones Clinicas

Caba, Buenos Aires, Argentina

Investigaciones Medicas IMOBA S.R.L.

Caba, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

Ciudad Autonoma de, Buenos Aires, Argentina

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

CIPADI

Godoy Cruz, Mendoza Province, Argentina

AXISMED SRL - Bioclinica Research Network

Buenos Aires, Argentina

CENUDIAB

Ciudad Autonoma de Buenos Aire, Argentina

Centro Médico Viamonte

Ciudad Autonoma de Buenos Aire, Argentina

Instituto Centenario

Ciudad Autonoma de Buenos Aire, Argentina

Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff

Ciudad Autonoma de Buenos Aire, Argentina

Mautalen Salud e Investigación - Servicio de Endocrinología

Ciudad Autonoma de Buenos Air, Argentina

Instituto Medico Strusberg

Córdoba, Argentina

Centro Medico Privado San Vicente Diabetes

Córdoba, Argentina

Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

Córdoba, Argentina

A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Dulaglutide

Ubicaciones

Centro Medico CICEMO

CEDIC-Centro de Investigaciones Clinicas

Investigaciones Medicas IMOBA S.R.L.

Centro de Investigaciones Metabólicas (CINME)

Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

Instituto de Investigaciones Clinicas Mar del Plata

CIPADI

AXISMED SRL - Bioclinica Research Network

CENUDIAB

Centro Médico Viamonte

Instituto Centenario

Cemediab - Centro Médico Diabetológico Dr. Alejandro Chertkoff

Mautalen Salud e Investigación - Servicio de Endocrinología

Instituto Medico Strusberg

Centro Medico Privado San Vicente Diabetes

Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

Patrocinadores