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

Type 2 Diabetes Clinical Trial

— QWINT-4  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462756
• Other study ID #: 18260
• Secondary ID: I8H-MC-BDCV2021-
• Status: Completed
• Phase: Phase 3
• Start date: August 11, 2022
• Est. completion date: February 27, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 730
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes
• Type 2 Diabetes Treated With Insulin

Intervention

Drug:
• Insulin Efsitora Alfa
Administered SC
• Insulin Lispro (U100)
Administered SC
• Insulin Glargine (U100)
Administered SC

Locations

Country	Name	City	State
Argentina	Mautalen Salud e Investigación	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	CEDIC	Caba	Buenos Aires
Argentina	CIPREC	Caba	Ciudad Autónoma De Buenos Aires
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	Consultorio de Investigación Clínica EMO SRL	Ciudad Autonoma de Buenos Aire	Buenos Air
Argentina	Centro de Investigaciones Metabólicas (CINME)	Ciudad Autónoma de Buenos Aire	Buenos Aires
Argentina	CENUDIAB	Ciudad Autónoma de Buenos Aires
Argentina	Instituto de Investigaciones Clínicas Córdoba	Córdoba
Argentina	Instituto Médico Río Cuarto	Río Cuarto	Córdoba
Argentina	Instituto de Investigaciones Clinicas Rosario-Sanatorio Delta	Rosario	Santa Fe
Argentina	Instituto Médico Catamarca IMEC	Rosario	Santa Fe
Argentina	Centro de Investigaciones Médicas Tucuman	SAN M. DE Tucuman	Tucumán
Argentina	Go Centro Medico San Nicolás	San Nicolas	Buenos Aires
Argentina	Centro de Investigaciones Clinicas del Litoral	Santa Fe
Argentina	Centro de Salud e Investigaciones Médicas	Santa Rosa	La Pampa
Germany	Diabetespraxis Mergentheim	Bad Mergentheim
Germany	InnoDiab Forschung Gmbh	Essen	Nordrhein-Westfalen
Germany	ClinPhenomics GmbH & Co KG	Frankfurt	Hessen
Germany	Diabeteszentrum Hamburg West	Hamburg
Germany	Institut für Diabetesforschung GmbH Münster	Münster	Nordrhein-Westfalen
Germany	Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage	Münster	Nordrhein-Westfalen
Germany	RED-Institut GmbH	Oldenburg	Schleswig-Holstein
India	Life Care Hospital and Research Centre	Bangalore	Karnataka
India	Post Graduate Institute of Medical Education & Research (PGIMER)	Chandigarh
India	Madras Diabetes Research Foundation	Chennai	Tamil Nadu
India	Osmania General Hospital	Hyderabad	Telangana
India	BSES MG Hospital	Mumbai	Maharashtra
India	Topiwala National Medical College & B. Y. L. Nair Charitable Hospital	Mumbai	Maharashtra
Italy	INRCA Ancona	Ancona
Italy	IRCCS - AOU di Bologna	Bologna
Italy	Azienda Ospedaliera Spedali Civili di Brescia	Brescia
Italy	Azienda Ospedaliera Mater Domini	Catanzaro
Italy	Osepdale Civile Fr 5	Ceccano	Frosinone
Italy	Ospedale san Giovanni di Dio-Diabetologia	Olbia	Sardegna
Italy	Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli	Palermo
Italy	"Fatebenefratelli Isola Tiberina - Gemelli Isola"	Roma	Lazio
Mexico	Investigacion En Salud Y Metabolismo Sc	Chihuahua
Mexico	Centro de Estudios de Investigacion Metabolicos y Cardiovasculares, S.C.	Ciudad Madero	Tamaulipas
Mexico	Private Practice - Dr. Arechavaleta Granell Maria del Rosario	Guadalajara	Jalisco
Mexico	Unidad de Investigación Clínica y Atención Médica HEPA	Guadalajara	Jalisco
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Unidad Médica para la Salud Integral	San Nicolás de los Garza	Nuevo León
Puerto Rico	Centro de Endocrinologia Alcantara Gonzalez	Bayamon
Puerto Rico	Manati Center for Clinical Research	Manati
Spain	CHUAC-Complejo Hospitalario Universitario A Coruña	A Coruña	A Coruña [La Coruña]
Spain	Hospital Universitario de La Ribera	Alzira	Valenciana, Comunitat
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya [Cataluña]
Spain	Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval	Ferrol	A Coruña [La Coruña]
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Andalucía
Spain	Hospital Universitari Son Espases	Palma	Balears [Baleares]
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcón	Madrid
Spain	Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)	Sevilla
Spain	Vithas Hospital Sevilla	Seville	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia	Valenciana, Comunitat
Spain	Hospital Clínico Universitario de Valladolid	Valladolid	Castilla Y León
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	Texas Diabetes & Endocrinology, P.A.	Austin	Texas
United States	MedStar Good Samaritan Hospital	Baltimore	Maryland
United States	Heritage Valley Multispecialty Group, Inc	Beaver	Pennsylvania
United States	Elite Clinical Trials	Blackfoot	Idaho
United States	Research Foundation of SUNY - University of Buffalo	Buffalo	New York
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Remington Davis Clinical Research	Columbus	Ohio
United States	North Texas Endocrine Center	Dallas	Texas
United States	Aventiv Research	Dublin	Ohio
United States	NECCR PrimaCare Research	Fall River	Massachusetts
United States	CMR of Greater New Haven, LLC	Hamden	Connecticut
United States	Biopharma Informatic, LLC	Houston	Texas
United States	Rocky Mountain Clinical Research	Idaho Falls	Idaho
United States	Palm Research Center Sunset	Las Vegas	Nevada
United States	Palm Research Center Tenaya	Las Vegas	Nevada
United States	Panax Clinical Research	Miami Lakes	Florida
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Research Institute of Dallas	Plano	Texas
United States	Rainier Clinical Research Center	Renton	Washington
United States	Chrysalis Clinical Research	Saint George	Utah
United States	Consano Clinical Research, LLC	Shavano Park	Texas
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	Encore Medical Research - Weston	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Germany,  India,  Italy,  Mexico,  Puerto Rico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in HbA1c	Change from Baseline in HbA1c of insulin efsitora alfa compared to insulin glargine on glycemic control in adult participants with type 2 diabetes on multiple daily injections.	Baseline, Week 26
Secondary	Percentage of Participants Achieving HbA1c <7% without Nocturnal Hypoglycemia	Percentage of participants achieving HbA1c <7% without nocturnal hypoglycemia milligram/deciliter (mg/dL) [3.0 millimole/Liter (mmol/L) or severe] during treatment phase up to week 26.	Week 26
Secondary	Nocturnal Hypoglycemia Event Rate	The event rate of participant-reported clinically significant nocturnal hypoglycemia <54 mg/dL (3.0 mmol/L) or severe) measured during treatment phase up to week 26.	Baseline to Week 26
Secondary	Change from Baseline in Fasting Glucose	Change from baseline in fasting glucose measured by small monitoring blood glucose (SMBG)	Baseline, Week 26
Secondary	Time in Glucose Range	Time in glucose range between 70 and 180 mg/dL (3.9 and 10.0 mmol/L), inclusive measured during the continuous glucose monitoring (CGM) session	Week 22 to Week 26
Secondary	Time in Hypoglycemia Range	Time in hypoglycemia range with glucose <54 mg/dL (3.0 mmol/L), measured by CGM	Week 22 to Week 26
Secondary	Time in Hyperglycemia Range	Time in hyperglycemia range with glucose >180 mg/dL (10.0 mmol/L), measured by CGM	Week 22 to Week 26
Secondary	Glucose Variability	Glucose variability measured during the CGM session	Week 22 to Week 26
Secondary	Basal Insulin Dose		Week 26
Secondary	Bolus Insulin Dose		Week 26
Secondary	Total Insulin Dose		Week 26
Secondary	Basal Insulin Dose to Total Insulin Dose Ratio		Week 26
Secondary	Hypoglycemia Event Rate	Incidence and rate of composite of level 2 and 3 hypoglycemia event	Baseline to Week 26
Secondary	Change from Baseline in Body Weight		Baseline, Week 26
Secondary	Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ)	The DID-EQ is a self-administered 10-item questionnaire designed to assess participants' perceptions of diabetes injection delivery systems for T2D. Each item is rated on a four-point Likert scale. Scores are transformed and range from 0 to 100. Higher scores indicate more positive perceptions of injection device characteristics.	Week 26

External Links

•   A Study of LY3209590 as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections (QWINT-4)