Clinical trial NCT05462756: A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Type 2 Diabetes Treated With Insulin
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c) [Noninferiority]
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Change From Baseline in HbA1c [Superiority]
timeFrame: Baseline, Week 26
measure: Percentage of Participants Achieving HbA1c <7% Without Nocturnal Hypoglycemia
timeFrame: Week 26
measure: Nocturnal Hypoglycemia Event Rate
timeFrame: Baseline Up To Week 26
measure: Change From Baseline in Fasting Glucose
timeFrame: Baseline, Week 26
measure: Percentage of Time in Glucose Range
timeFrame: Week 22 to Week 26
measure: Percentage of Time in Hypoglycemia Range
timeFrame: Week 22 to Week 26
measure: Percentage of Time in Hyperglycemia Range
timeFrame: Week 22 to Week 26
measure: Glucose Variability Between Weeks 22 to 26
timeFrame: Week 22 to Week 26
measure: Basal Insulin Dose at Week 26
timeFrame: Week 26
measure: Bolus Insulin Dose at Week 26
timeFrame: Week 26
measure: Total Insulin Dose at Week 26
timeFrame: Week 26
measure: Basal Insulin Dose to Total Insulin Dose Ratio at Week 26
timeFrame: Week 26
measure: Hypoglycemia Event Rate
timeFrame: Baseline up to Week 26
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Week 26
measure: Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ)
timeFrame: Week 26
Other outcomes:
Locations:
city: Hamden
country: United States
facility: CMR of Greater New Haven, LLC
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Miami Lakes
country: United States
facility: Panax Clinical Research
state: Florida
city: Weston
country: United States
facility: Encore Medical Research - Weston
state: Florida
city: Blackfoot
country: United States
facility: Elite Clinical Trials
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Baltimore
country: United States
facility: MedStar Good Samaritan Hospital
state: Maryland
city: Fall River
country: United States
facility: NECCR PrimaCare Research
state: Massachusetts
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: Buffalo
country: United States
facility: Research Foundation of SUNY - University of Buffalo
state: New York
city: Columbus
country: United States
facility: Remington Davis Clinical Research
state: Ohio
city: Dublin
country: United States
facility: Aventiv Research
state: Ohio
city: Beaver
country: United States
facility: Heritage Valley Multispecialty Group, Inc
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Austin
country: United States
facility: Texas Diabetes & Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Plano
country: United States
facility: Research Institute of Dallas
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Caba
country: Argentina
facility: CEDIC
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aire
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
state: Buenos Aires
city: San Nicolas
country: Argentina
facility: Go Centro Medico San Nicolás
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Buenos Air
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Caba
country: Argentina
facility: Instituto Centenario
state: Ciudad Autónoma De Buenos Aire
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aire
city: Río Cuarto
country: Argentina
facility: Instituto Médico Río Cuarto
state: Córdoba
city: Santa Rosa
country: Argentina
facility: Centro de Salud e Investigaciones Médicas
state: La Pampa
city: Rosario
country: Argentina
facility: Instituto de Investigaciones Clinicas Rosario-Sanatorio Delta
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Médico Catamarca IMEC
state: Santa Fe
city: San Miguel De Tucumán
country: Argentina
facility: Centro de Investigaciones Médicas Tucuman
state: Tucumán
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: CENUDIAB
city: Córdoba
country: Argentina
facility: Instituto de Investigaciones Clínicas Córdoba
city: Santa Fe
country: Argentina
facility: Centro de Investigaciones Clinicas del Litoral
city: Frankfurt
country: Germany
facility: ClinPhenomics GmbH & Co KG
state: Hessen
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Institut für Diabetesforschung GmbH Münster
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
state: Nordrhein-Westfalen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Bad Mergentheim
country: Germany
facility: Diabetespraxis Mergentheim
city: Hamburg
country: Germany
facility: Diabeteszentrum Hamburg West
city: Bangalore
country: India
facility: Life Care Hospital and Research Centre
state: Karnataka
city: Mumbai
country: India
facility: Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
state: Maharashtra
city: Mumbai
country: India
facility: BSES MG Hospital
state: Maharashtra
city: Chennai
country: India
facility: Madras Diabetes Research Foundation
state: Tamil Nadu
city: Hyderabad
country: India
facility: Osmania General Hospital
state: Telangana
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education & Research (PGIMER)
city: Ceccano
country: Italy
facility: Osepdale Civile Fr 5
state: Frosinone
city: Roma
country: Italy
facility: "Fatebenefratelli Isola Tiberina - Gemelli Isola"
state: Lazio
city: Olbia
country: Italy
facility: Ospedale san Giovanni di Dio-Diabetologia
state: Sardegna
city: Ancona
country: Italy
facility: INRCA Ancona
city: Bologna
country: Italy
facility: IRCCS - AOU di Bologna
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili di Brescia
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini
city: Palermo
country: Italy
facility: Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
city: Guadalajara
country: Mexico
facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario
state: Jalisco
city: Guadalajara
country: Mexico
facility: Unidad de Investigación Clínica y Atención Médica HEPA
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
state: Nuevo León
city: San Nicolás de los Garza
country: Mexico
facility: Unidad Médica para la Salud Integral
state: Nuevo León
city: Ciudad Madero
country: Mexico
facility: Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.
state: Tamaulipas
city: Chihuahua
country: Mexico
facility: Investigacion En Salud Y Metabolismo Sc
city: Bayamon
country: Puerto Rico
facility: Centro de Endocrinologia Alcantara Gonzalez
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research
city: A Coruña
country: Spain
facility: CHUAC-Complejo Hospitalario Universitario A Coruña
state: A Coruña [La Coruña]
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
state: A Coruña [La Coruña]
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
state: Andalucía
city: Palma
country: Spain
facility: Hospital Universitari Son Espases
state: Balears [Baleares]
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
state: Castilla Y León
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya [Cataluña]
city: Pozuelo de Alarcón
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Seville
country: Spain
facility: Vithas Hospital Sevilla
state: Sevilla
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera
state: Valenciana, Comunitat
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Valenciana, Comunitat
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio
city: Sevilla
country: Spain
facility: Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) Mon- Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: