Efficacy and Safety of Tirzepatide Once Weekly in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-2)

CompletadoFase 3ClinicalTrials.gov

ID: NCT04657003Tipo: INTERVENTIONALInicio: 29 de mar de 2021Fin estimado: 10 de abr de 2023

Traducción no disponible, mostrando original

Resumen

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight. The main purpose is to learn more about how tirzepatide affects body weight. The study will last 79 weeks (22 visits).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have Type 2 Diabetes (T2DM) with HbA1c ≥7% to ≤10% at screening, on stable therapy for the last 3 months prior to screening. T2DM may be treated with diet/exercise alone or any oral glycemic-lowering agent (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or glucagon like peptide-1 receptor agonists (GLP-1 RAs)
Have a BMI of ≥27 kg/m²
Are overweight or have obesity
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
Are at least 18 years of age and age of majority per local laws and regulations

Criterios de exclusión

Have Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except T2DM
Have at least 2 confirmed fasting self-monitoring blood glucose (SMBG) values \>270 mg/dL(on 2 nonconsecutive days) prior to Visit 3
Have proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment
Have self-reported change in body weight \>5kg within 3 months prior to screening
Have had a history of chronic or acute pancreatitis
Change in body weight greater than 5 kg within 3 months prior to starting study
Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
Any lifetime history of a suicide attempt

Intervenciones

drug

Tirzepatide

Administered SC

other

Placebo

Administered SC

Ubicaciones

Consultorio de Investigación Clínica EMO SRL

Ciudad Autonoma de Buenos Aire, Buenos Aires, Argentina

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

Centro Médico Viamonte

Buenos Aires, Ciudad Autónoma de Buenos Aire, Argentina

CIPREC

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Centro de Investigaciones Médicas Tucuman

SAN M. de Tucuman, Tucumán Province, Argentina

Sanatorio Norte

Santiago del Estero, Argentina

Patrocinadores

PrincipalEli Lilly and Company

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