A Randomized, Phase 3, Open-label Trial Comparing the Effect of the Addition of Tirzepatide Once Weekly Versus Insulin Lispro (U100) Three Times Daily in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin (SURPASS-6)

CompletadoFase 3ClinicalTrials.gov

ID: NCT04537923Tipo: INTERVENTIONALInicio: 19 de oct de 2020Fin estimado: 1 de nov de 2022

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have been diagnosed with type 2 diabetes mellitus (T2DM)
Have HbA1c between ≥7.5% and ≤11%
Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors
Be of stable weight (± 5%) for at least 90 days
Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 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 macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility
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 weight loss drugs, including over-the-counter medications during the last 3 months
Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m² \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]

Intervenciones

drug

Tirzepatide

Administered SC

drug

Insulin Lispro (U100)

Administered SC

Ubicaciones

Centro Médico Viamonte

CABA, Buenos Aires, Argentina

Investigaciones Medicas Imoba Srl

CABA, Buenos Aires, Argentina

Instituto Centenario

CABA, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Rosario (IIC-Rosario)- Sanatorio Delta

Rosario, Buenos Aires, Argentina

CIPADI

Godoy Cruz, Mendoza Province, Argentina

Instituto Médico Catamarca

Rosario, Santa Fe Province, Argentina

Instituto Médico Especializado (IME)

Buenos Aires, Argentina

Asociación de Beneficencia Hospital Sirio Libanés

Buenos Aires, Argentina

CENUDIAB

Ciudad Autónoma de Buenos Aire, Argentina

Centro Diabetologico Dr Waitman

Córdoba, Argentina

Centro Medico Privado San Vicente Diabetes

Córdoba, Argentina

Sanatorio Parque

Salta, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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