A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared With Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes

Activo, no reclutaFase 4ClinicalTrials.gov

ID: NCT05433584Tipo: INTERVENTIONALInicio: 1 de ago de 2022Fin estimado: 1 de nov de 2027

Traducción no disponible, mostrando original

Resumen

This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have, within the last 4 years, been diagnosed with T2D based on the World Health Organization classification or other locally applicable diagnostic standards.
Have HbA1c ≥7% to ≤9.5% as determined by the central laboratory.
Have been on a stable treatment of metformin only at least 90 days preceding baseline
with the minimum effective dose of ≥1500 mg/day, but not higher than the maximum approved dose per country-specific label, or
\<1500 mg/day in case of intolerance of full therapeutic dose.

Criterios de exclusión

Have type 1 diabetes mellitus
Have a history of chronic or acute pancreatitis any time prior to study entry
Have a history of
proliferative diabetic retinopathy
diabetic macular edema, or
no proliferative diabetic retinopathy requiring immediate or urgent treatment
Are at high risk for cardiovascular disease (CVD) in the investigator's opinion or have a history of any of these CV conditions prior to study entry
myocardial infarction
percutaneous coronary revascularization procedure
carotid stenting or surgical revascularization
nontraumatic amputation
peripheral vascular procedure (e.g., stenting or surgical revascularization)
cerebrovascular accident (stroke), or congestive heart failure
Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2)
Have within 90 days prior to screening received treatment with medications intended to promote weight loss. This includes prescribed, over the counter, or alternative remedies
Have an estimated glomerular filtration rate (eGFR) \<30 mL/minute/1.73 m2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by chronic kidney disease-epidemiology equation as determined by central laboratory at screening.
Have been treated with any injectable glucagon-like peptide-1 (GLP-1) receptor agonists and insulin prior to screening.
Exception: use of insulin for gestational diabetes or short-term use (\<14 days) for acute conditions such as acute illness, hospitalization, or elective surgery.

Intervenciones

drug

Tirzepatide

Administered SC

drug

Antihyperglycemic medication

As prescribed

Ubicaciones

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Go Centro Medico San Nicolás

San Nicolás de los Arroyos, Buenos Aires, Argentina

CIAD Moron

Morón, Buenos Air, Argentina

Centro Médico Viamonte

Buenos Aires, Ciudad Aut, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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