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

Status: Recruiting
Location: See all (83) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The reason for this study is to evaluate if the once-weekly study drug 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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)

Locations
United States
Connecticut
CMR of Greater New Haven
Recruiting
Hamden
Florida
Tampa Bay Medical Research
Recruiting
Clearwater
Panax Clinical Research
Recruiting
Miami Lakes
Encore Medical Research - Weston
Recruiting
Weston
Idaho
Elite Clinical Trials
Recruiting
Blackfoot
Rocky Mountain Clinical Research
Recruiting
Idaho Falls
Massachusetts
NECCR PrimaCare Research
Recruiting
Fall River
Maryland
MedStar Good Samaritan Hospital
Recruiting
Baltimore
Michigan
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Recruiting
Troy
Nevada
Palm Research Center Sunset
Recruiting
Las Vegas
Palm Research Center Tenaya
Recruiting
Las Vegas
New York
Research Foundation of SUNY - University of Buffalo
Recruiting
Buffalo
Ohio
Remington Davis Clinical Research
Recruiting
Columbus
Aventiv Research
Recruiting
Dublin
Pennsylvania
Heritage Valley Medical Group, Inc.
Recruiting
Beaver
Thomas Jefferson University - Clinical Research Institute
Not yet recruiting
Philadelphia
Texas
Texas Diabetes & Endocrinology, P.A.
Recruiting
Austin
Texas Diabetes & Endocrinology, P.A.
Recruiting
Austin
North Texas Endocrine Center
Recruiting
Dallas
Biopharma Informatic, LLC
Recruiting
Houston
Research Institute of Dallas
Recruiting
Plano
Consano Clinical Research, LLC
Recruiting
Shavano Park
Utah
Chrysalis Clinical Research
Recruiting
Saint George
Washington
Rainier Clinical Research Center
Recruiting
Renton
Other Locations
Argentina
Mautalen Salud e Investigación
Recruiting
Buenos Aires
CEDIC
Recruiting
Caba
CIPREC
Recruiting
Caba
Instituto Centenario
Recruiting
Caba
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Recruiting
Ciudad Autonoma De Buenos Aire
Consultorio de Investigación Clínica EMO SRL
Recruiting
Ciudad Autonoma De Buenos Aire
Centro de Investigaciones Metabólicas (CINME)
Recruiting
Ciudad Autónoma De Buenos Aire
CENUDIAB
Recruiting
Ciudad Autónoma De Buenos Aire
Instituto de Investigaciones Clínicas Córdoba
Recruiting
Córdoba
Instituto Médico Río Cuarto
Recruiting
Río Cuarto
Instituto de Investigaciones Clinicas Rosario
Recruiting
Rosario
Instituto Médico Catamarca IMEC
Recruiting
Rosario
Centro de Investigaciones Médicas Tucuman
Recruiting
San M. De Tucuman
Go Centro Medico San Nicolás
Not yet recruiting
San Nicolas
Centro de Investigaciones Clinicas del Litoral
Recruiting
Santa Fe
Centro de Salud e Investigaciones Médicas
Recruiting
Santa Rosa
Germany
Diabetespraxis Mergentheim
Recruiting
Bad Mergentheim
InnoDiab Forschung Gmbh
Recruiting
Essen
ClinPhenomics CVC GmbH
Recruiting
Frankfurt
Diabeteszentrum Hamburg West
Recruiting
Hamburg
Institut für Diabetesforschung GmbH Münster
Recruiting
Münster
Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage
Recruiting
Münster
RED-Institut GmbH
Recruiting
Oldenburg
India
Life Care Hospital and Research Centre
Not yet recruiting
Bangalore
Postgraduate Institute of Medical Education & Research
Not yet recruiting
Chandigarh
Madras Diabetes Research Foundation
Not yet recruiting
Chennai
Osmania General Hospital
Not yet recruiting
Hyderabad
BSES MG Hospital
Not yet recruiting
Mumbai
Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
Not yet recruiting
Mumbai
Italy
INRCA Ancona
Not yet recruiting
Ancona
IRCCS - AOU di Bologna
Not yet recruiting
Bologna
Azienda Ospedaliera Spedali Civili di Brescia
Not yet recruiting
Brescia
Azienda Ospedaliera Mater Domini
Not yet recruiting
Catanzaro
Osepdale Civile Fr 5
Not yet recruiting
Ceccano
Ospedale Luigi Sacco
Not yet recruiting
Milan
Ospedale san Giovanni di Dio-Diabetologia
Not yet recruiting
Olbia
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Not yet recruiting
Palermo
Fatebenefratelli Isola Tiberina - Gemelli Isola
Not yet recruiting
Roma
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Not yet recruiting
Torino
Mexico
Investigacion En Salud Y Metabolismo Sc
Recruiting
Chihuahua
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Not yet recruiting
Ciudad Madero
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Not yet recruiting
Guadalajara
Unidad de Investigación Clínica y Atención Médica HEPA
Not yet recruiting
Guadalajara
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Not yet recruiting
Monterrey
Unidad Médica para la Salud Integral
Not yet recruiting
San Nicolás De Los Garza
Puerto Rico
Centro de Endocrinologia Alcantara Gonzalez
Recruiting
Bayamon
Manati Center for Clinical Research
Recruiting
Manati
Spain
CHUAC-Complejo Hospitalario Universitario A Coruña
Recruiting
A Coruña
Hospital Universitario de La Ribera
Recruiting
Alzira
Hospital de la Santa Creu i Sant Pau
Recruiting
Barcelona
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Recruiting
Ferrol
Hospital Universitario San Cecilio
Recruiting
Granada
Hospital Universitario Virgen de la Victoria
Recruiting
Malaga
Hospital Universitari Son Espases
Recruiting
Palma
Hospital Universitario Quironsalud Madrid
Recruiting
Pozuelo De Alarcón
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Recruiting
Sevilla
Vithas Hospital Sevilla
Recruiting
Seville
Hospital General Universitario de Valencia
Recruiting
Valencia
Hospital Clínico Universitario de Valladolid
Recruiting
Valladolid
Contact Information
Primary
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
ClinicalTrials.gov@lilly.com
1-317-615-4559
Time Frame
Start Date: August 11, 2022
Estimated Completion Date: October 17, 2023
Participants
Target number of participants: 670
Treatments
Experimental: LY3209590 + Insulin Lispro
Participants will be given LY3209590 by subcutaneous (SC) injection along with insulin lispro
Active Comparator: Insulin Glargine + Insulin Lispro
Participants will be given insulin glargine by SC injection along with insulin lispro
Authors
Serge Jabbour, Betsy Palal, Sandro Bacchelli, Manoj Chawla, Thomas Blevins, Elena A Christofides, Tamer Yacoub, Ajay Chaudhuri, Robert Godfrey Perry, Peter Edward Bressler, Joseph H Woolley, Gary W Soucie, Michael J Oliver, Samer Nakhle, Adline Ghazi, Carl D Vance, Joseph Soufer, Jose Gerardo Gonzalez-Gonzalez, Ramon Ortiz-Carrasquillo, Michelle Welch, Frances Eileen Broyles, Roy C St. John, Donald Franklin Gardner, Sureka Bollepalli, Neil J. Fraser, Heidi Chamberlain Shea, Luis Alejandro Nevarez, Bernhard Rudolf Winkelmann, Dominik Dahl, Ludger Rose, Thomas Schaum, Simon Vidal, Winfried Keuthage, salvatore corrao, Natacha Maldonado, Jugal Velji Gada, carmen fajardo, Marcos Alejandro Mayer, Kudugunti Neelaveni, Pablo Rene Costanzo, Federico C. Perez Manghi, Rodrigo Carnero, Maria Jimena Coronel, Tira Chaicha- Brom, Altagracia Aurora Alcantara -Gonzalez, Maria Cecilia Cantero, Dina María Salica, Ines Palmira Bartolacci, Sreenivasa Murthy, Rama Walia, Elena Tortato, SUSANA SALZBERG, ROSA CORCOY, Giancarlo Tonolo, Esteban Jodar Gimeno, Cristobal Jesus Morales Portillo, Cesar Javier Zaidman, Maximiliano Sicer, Rafael Margarito Violante Ortiz, Paulina Virginia Lanchiotti, Helga Zeller, Elizabeth Gelersztein, Ramiro Guadalupe Banda Elizondo, Alberto Aliaga Verdugo, José Osvaldo Fretes, Alejandra Isabel Oviedo, Uberto Pagotto, VISWANATHAN MOHAN, Agostino Gnasso, Nicola Napoli, Angela Girelli, Daniel De luis roman, Alfonso Soto Gonzalez, Marisol Herrera Marmolejo, Paolo Fiorina, Miguel Quesada Charneco, Fabio Broglio, Santiago Tofe Povedano, Simona Frontoni, Juan Carlos Ferrer Garcia, Francisco Jose Tinahones Madueno, Maria del Rosario Del Rosario Arechavaleta Granell
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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