Resumen

The reason for this study is to evaluate if the once-weekly study drug insulin efsitora alfa (LY3209590) is safe and effective compared with daily insulin glargine in participants with Type 2 diabetes (T2D) that have already been treated with basal insulin and at least 2 injections per day of prandial insulin. The study consists of a 3-week screening/lead-in period, a 26-week treatment period and a 5-week safety follow-up period. The study will last up to 34 weeks.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have a diagnosis of T2D according to the world health organization (WHO) criteria, currently treated with basal insulin and at least 2 injections of prandial insulin per day.
Are receiving ≥10 units of total basal insulin per day at screening.
Are receiving ≤2 units/kilogram/day of total daily insulin at screening
Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central laboratory at screening
Have been treated with a stable regimen of one of the following basal insulins used according to local product label with or without noninsulin diabetes therapy for at least 90 days prior to screening
once daily U-100 or U-200 insulin degludec
once daily U-100 or U-300 insulin glargine
once or twice daily U-100 insulin detemir or
once or twice daily human insulin Neutral Protamine Hagedorn
Have been treated with at least twice daily dosing of one of the following insulins used according to local product label for at least 90 days prior to screening. One dose of prandial insulin must occur at the evening meal.
Insulin lispro-aabc
Insulin lispro (U-100 and U-200)s, IN\], U-100 or U200)
Insulin aspart (U-100)
Insulin glulisine (U-100), or
Regular insulin (U-100)
Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days prior to screening
dipeptidyl peptidase IV inhibitors
sodium-glucose co-transporter-2 inhibitors
biguanides (for example, metformin), or
glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes therapies must be used in accordance with the corresponding local product label at the time of screening, and participants should be willing to continue stable dosing throughout the study
Have a body mass index ≤45 kilogram/square meter (kg/m²)

Criterios de exclusión

Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D (for example, monogenic diabetes, diseases of the exocrine pancreas, drug-induced or chemical-induced diabetes).
Are currently receiving any of the following insulin therapies anytime in the past 90 days:
insulin mixtures
insulin human, inhalation powder, or
continuous subcutaneous insulin infusion therapy, or
regular insulin U-500
Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
Have had any episodes of severe hypoglycemia, defined as requiring assistance due to neurologically disabling hypoglycemia, within the 6 months prior to screening
Have hypoglycemia unawareness in the opinion of the investigator
Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for example, initiation, stopping, or changing device) during the study.
Have had New York Heart Association Class IV heart failure or any of the following cardiovascular conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or sleeve gastrectomy within 1 year prior to screening

Ubicaciones

CEDIC

CABA, Buenos Aires, Argentina

Centro de Investigaciones Metabólicas (CINME)

Ciudad Autónoma de Buenos Aire, Buenos Aires, Argentina

Go Centro Medico San Nicolás

San Nicolás de los Arroyos, Buenos Aires, Argentina

Mautalen Salud e Investigación

Buenos Aires, Buenos Aires F.D., Argentina

CIPREC

CABA, Buenos Aires F.D., Argentina

Consultorio de Investigación Clínica EMO SRL

Ciudad Autonoma de Buenos Aire, Buenos Air, Argentina

Instituto Centenario

CABA, Ciudad Autónoma de Buenos Aire, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

Centro de Salud e Investigaciones Médicas

Santa Rosa, La Pampa Province, Argentina

Instituto de Investigaciones Clinicas Rosario-Sanatorio Delta

Rosario, Santa Fe Province, Argentina

Instituto Médico Catamarca IMEC

Rosario, Santa Fe Province, Argentina

Centro de Investigaciones Médicas Tucuman

San Miguel de Tucumán, Tucumán Province, Argentina

CENUDIAB

Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Córdoba

Córdoba, Argentina

Centro de Investigaciones Clinicas del Litoral

Santa Fe, Argentina

A Phase 3, Parallel-Design, Open-Label, Randomized Controlled Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adults With Type 2 Diabetes on Multiple Daily Injections