Resumen

The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin
Are receiving ≥10 units of basal insulin per day and ≤110 units per day at screening
Have HbA1c value of 6.5% - 10% inclusive, at screening
Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m²)
Have been treated with one of the following stable insulin regimens at least 90 days prior to screening:
once daily U100 or U200 of insulin degludec
once daily U100 or U300 of insulin glargine
once or twice daily U100 of insulin detemir, or
once or twice daily human insulin NPH
acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
dipeptidyl peptidase (DPP-4) IV inhibitors
SGLT2 inhibitors
metformin
alphaglucosidase inhibitors or,
Glucagon-Like Peptide-1 (GLP-1) receptor agonists
Participants must be willing to stay on stable dose throughout the study

Criterios de exclusión

Have Type 1 diabetes mellitus
Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD)
Estimated glomerular filtration rate (eGFR) \<20 milliliters/minute/1.73 square meter (m²)
Have active or untreated malignancy
Are pregnant
Have a significant weight gain or loss the past 3 months
Have received anytime in the past 6 months, any of the following insulin therapies:
prandial insulin
insulin mixtures
inhaled insulin
U-500 insulin, or
continuous subcutaneous insulin infusion therapy
Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
acute myocardial infarctions
cerebrovascular accident (stroke), or
coronary bypass surgery
Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening

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

Consultorio de Investigación Clínica EMO SRL

Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina

Stat Research S.A.

Ciudad Autónoma de Buenos Aire, Buenos Air, Argentina

Centro Médico Viamonte

Buenos Aires, Ciudad Aut, Argentina

Mautalen Salud e Investigación

Buenos Aires, Ciudad Aut, Argentina

Instituto Centenario

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina

CIPADI - Centro Integral de Prevencion y Atencion en Diabetes

Godoy Cruz, Mendoza Province, Argentina

Instituto Médico Catamarca IMEC

Rosario, Santa Fe Province, Argentina

CEMEDIC

Buenos Aires, Argentina

CENUDIAB

Ciudad Autónoma de Buenos Aire, Argentina

Centro Diabetológico Dr. Waitman

Córdoba, Argentina

A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)