A Randomized, Phase 3, Open-Label Trial Comparing the Effect of LY3298176 Versus Titrated Insulin Degludec on Glycemic Control in Patients With Type 2 Diabetes

CompletadoFase 3ClinicalTrials.gov

ID: NCT03882970Tipo: INTERVENTIONALInicio: 1 de abr de 2019Fin estimado: 4 de ene de 2021

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the effect of the study drug tirzepatide to insulin degludec on blood sugar levels in participants with type 2 diabetes. The study will last about 67 weeks and may include up to 22 visits.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must:
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 or metformin plus an SGLT-2 inhibitor for at least 3 months before screening
Be of stable weight (± 5%) for at least 3 months before screening
Have a BMI ≥25 kilograms per meter squared (kg/m2) at screening

Criterios de exclusión

Participants must not:
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 their ALT level is ≤3.0 the ULN for the reference range
Have an estimated glomerular filtration rate \<45 mL/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, or metformin plus an SGLT-2 inhibitor 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

Insulin Degludec

Administered SC

Ubicaciones

Mautalen Salud e Investigación - Servicio de Endocrinología

CABA, Buenos Aires, Argentina

Investigaciones Medicas IMOBA S.R.L.

Caba, Buenos Aires, Argentina

CEDIC-Centro de Investigaciones Clinicas

Caba, Buenos Aires, Argentina

Centro de Investigacion y Prevencion Cardiovascular (CIPREC)

Ciudad Autonoma de, Buenos Aires, Argentina

CIPADI

Godoy Cruz, Mendoza Province, Argentina

AXISMED SRL - Bioclinica Research Network

Buenos Aires, Argentina

Centro Médico Viamonte

Ciudad Autonoma de Buenos Aire, Argentina

Instituto Centenario

Ciudad Autonoma de Buenos Aire, Argentina

CENUDIAB

Ciudad Autonoma de Buenos Aire, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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