A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of Tirzepatide Versus Semaglutide Once Weekly as Add-on Therapy to Metformin in Patients With Type 2 Diabetes

CompletadoFase 3ClinicalTrials.gov

ID: NCT03987919Tipo: INTERVENTIONALInicio: 30 de jul de 2019Fin estimado: 15 de feb de 2021

Traducción no disponible, mostrando original

Resumen

The reason for this study is to compare the effect of the study drug tirzepatide to semaglutide on blood sugar levels in participants with type 2 diabetes. The study will last approximately 47 weeks and may include about 12 visits.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have been diagnosed with type 2 diabetes mellitus (T2DM)
Have HbA1c between ≥7.0% and ≤10.5%
Be on stable treatment with unchanged dose of metformin \>1500 mg/day for at least 3 months prior to screening
Be of stable weight (±5%) for at least 3 months before screening
Have a body mass index (BMI) ≥25 kilograms per meter squared (kg/m²) at screening

Criterios de exclusión

Have type 1 diabetes mellitus
Have had chronic or acute pancreatitis any time prior to study entry
Have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment
Have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss
Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or blood alanine transaminase (ALT) enzyme level \>3.0 times the upper limit of normal (ULN) for the reference range, as determined by the central laboratory. Participants with nonalcoholic fatty liver disease (NAFLD) are eligible for participation in this trial only if there ALT level is ≤3.0 the ULN for the reference range
Have an estimated glomerular filtration rate \<45 milliliters/minute/1.73 m² (or lower than the country specific threshold for using the protocol required dose of metformin per local label)
Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
Have been taking any other diabetes medicines other than metformin during the last 3 months
Have been taking weight loss drugs, including over-the-counter medications during the last 3 months

Intervenciones

drug

Tirzepatide

Administered SC

drug

Semaglutide

Administered SC

Ubicaciones

CEDIC

CABA, AR-B, Argentina

CIPREC

Ciudad Autonoma de Buenos Aire, AR-B, Argentina

Investigaciones Medicas Imoba Srl

Buenos Aires, AR-C, Argentina

CEMEDIAB

C.a.b.a., AR-C, Argentina

Sanatorio Norte

Santiago del Estero, AR-G, Argentina

Centro de Investigaciones Metabólicas (CINME)

CABA, Buenos Aires, Argentina

Centro Médico Viamonte

CABA, Buenos Aires, Argentina

Centro Medico Dr Laura Maffei Investigacion Clinica Aplicada

CABA, Buenos Aires, Argentina

Mautalen Salud e Investigacion-Centro de Osteopatías Médicas

Ciudad Autonoma de Buenos Air, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

CIPADI

Godoy Cruz, Mendoza Province, Argentina

Instituto Centenario

Ciudad Autonoma de Buenos Aire, Argentina

Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

Córdoba, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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