A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Study to Evaluate the Efficacy and Safety of LY3209590 as a Weekly Basal Insulin Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy

Status: Recruiting
Location: See all (87) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The main purpose of this study is to measure the safety and efficacy of LY3209590 compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Have a clinical diagnosis of type 1 diabetes for at least 1 year prior to screening

• Have received treatment with basal-bolus insulin analog multiple daily injection therapy according to the local product label for at least 90 days prior to screening

• Have an HbA1c value of 7.0% to 10.0%, inclusive, as determined by the central laboratory at screening.

• Have a body mass index of ≤35 kilogram/square meter (kg/m²)

Locations
United States
California
John Muir Physician Network Research Center
Recruiting
Concord
Valley Research
Recruiting
Fresno
Catalina Research Institute, LLC
Recruiting
Montclair
Sansum Diabetes Research Institute
Recruiting
Santa Barbara
University Clinical Investigators, Inc.
Recruiting
Tustin
Colorado
University of Colorado Anschutz Medical Campus
Recruiting
Aurora
Florida
Northeast Research Institute (NERI)
Recruiting
Fleming Island
Jellinger and Lerman, MD PA dba The Center for Diabetes and Endocrine Care
Recruiting
Fort Lauderdale
Suncoast Clinical Research, Inc.
Recruiting
New Port Richey
Hanson Clinical Research Center
Recruiting
Port Charlotte
Georgia
East Coast Institute for Research, LLC
Recruiting
Macon
Hawaii
East-West Medical Research Institute
Recruiting
Honolulu
Iowa
Iowa Diabetes and Endocrinology Research Center
Recruiting
West Des Moines
Idaho
Rocky Mountain Clinical Research
Recruiting
Idaho Falls
Kansas
Cotton O'Neil Clinical Research Center
Recruiting
Topeka
Maryland
MedStar Health Research Institute (MedStar Physician Based Research Network)
Recruiting
Hyattsville
Endocrine and Metabolic Consultants
Recruiting
Rockville
Missouri
Clinvest Research LLC
Recruiting
Springfield
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
NYU Langone Hospital - Long Island
Recruiting
Mineola
NYC Research
Recruiting
New York
SUNY Upstate Medical University
Recruiting
Syracuse
Pennsylvania
Thomas Jefferson University - Clinical Research Institute
Not yet recruiting
Philadelphia
Texas
Texas Diabetes & Endocrinology, P.A.
Recruiting
Austin
Dallas Diabetes Research Center
Recruiting
Dallas
North Texas Endocrine Center
Recruiting
Dallas
Research Institute of Dallas
Recruiting
Dallas
Amir A Hassan, MD, PA
Recruiting
Houston
Biopharma Informatic, LLC
Recruiting
Houston
Southern Endocrinology Associates
Recruiting
Mesquite
Texas Diabetes & Endocrinology, P.A.
Recruiting
Round Rock
Washington
Rainier Clinical Research Center
Recruiting
Renton
Other Locations
Argentina
Instituto Médico Especializado (IME)
Recruiting
Buenos Aires
Investigaciones Medicas Imoba Srl
Recruiting
Buenos Aires
Mautalen Salud e Investigación
Recruiting
Buenos Aires
CEDIC
Recruiting
Caba
Centro Medico Privado CEMAIC
Recruiting
Capital
Consultorio de Investigación Clínica EMO SRL
Recruiting
Ciudad Autonoma De Buenos Aire
Centro de Investigaciones Metabólicas (CINME)
Recruiting
Ciudad Autónoma De Buenos Aire
Centro Diabetológico Dr. Waitman
Recruiting
Cordoba
Centro Medico Privado San Vicente Diabetes
Recruiting
Cordoba
CIPADI - Centro Integral de Prevencion y Atencion en Diabetes
Recruiting
Godoy Cruz
CIAD Moron
Recruiting
Moron
Centro de Investigaciones Médicas Tucuman
Recruiting
San M. De Tucuman
Clínica Mayo
Recruiting
San Miguel De Tucuman
Centro de Salud e Investigaciones Médicas
Recruiting
Santa Rosa
India
Victoria Hospital, Bangalore Medical College And Research Institute
Recruiting
Bangalore
Kumudini Devi Diabetes Research Center
Not yet recruiting
Hyderabad
Nirmal Hospital Pvt Ltd.
Recruiting
Surat
Japan
The Institute of Medical Science, Asahi Life Foundation
Recruiting
Chuo-ku
Clinic Masae Minami
Recruiting
Fukuoka
Hachioji Diabetes Clinic
Recruiting
Hachioji
Takai Internal Medicine Clinic
Recruiting
Kamakura-shi
Jinnouchi Hospital
Recruiting
Kumamoto
MinamiAkatsukaClinic
Recruiting
Mito
Heiwadai Hospital
Recruiting
Miyazaki
Tosaki Clinic for Diabetes and Endocrinology
Recruiting
Nagoya-shi
Nakakinen clinic
Recruiting
Naka
Abe Clinic
Recruiting
Oita
Shimizu Clinic Fusa
Recruiting
Saitama-shi
Manda Memorial Hospital
Recruiting
Sapporo
Yuri Ono Clinic
Recruiting
Sapporo
Takatsuki Red Cross Hospital
Recruiting
Takatsuki
Noritake Clinic
Recruiting
Ushiku
Poland
NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
Recruiting
Bialystok
SN ZOZ Lege Artis Poradnia Diabetologiczna
Recruiting
Bialystok
Centrum Badan Klinicznych PI-House sp. z o.o.
Recruiting
Gdansk
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
Recruiting
Krakow
Gabinety TERPA
Recruiting
Lublin
NZOZ Medica
Recruiting
Lublin
Centrum Medyczne Diabetika
Recruiting
Radom
Centralny Szpital Kliniczny MSWiA w Warszawie
Recruiting
Warszawa
NBR Polska
Recruiting
Warszawa
Private Practice - Dr. Janusz Gumprecht
Recruiting
Zabrze
Puerto Rico
Advanced Clinical Research, LLC
Recruiting
Bayamon
Private Practice Dr. Martha Gomez Cuellar
Recruiting
San Juan
Slovakia
ENDIAMED s.r.o
Recruiting
Dolny Kubin
FUNKYSTUFF s.r.o.
Recruiting
Nove Zamky
Tatratrial s.r.o.
Recruiting
Rožňava
Taiwan
Changhua Christian Hospital
Recruiting
Changhua County
Chung Shan Medical University Hospital
Recruiting
Taichung City
Taichung Veterans General Hospital
Recruiting
Taichung City
National Cheng-Kung Uni. Hosp.
Recruiting
Tainan
Chi Mei Medical Center
Recruiting
Tainan City
Taipei Veterans General Hospital
Recruiting
Taipei City
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 12, 2022
Estimated Completion Date: April 19, 2024
Participants
Target number of participants: 670
Treatments
Experimental: LY3209590
Participants will receive LY3209590 by subcutaneously (SC)
Active Comparator: Insulin Degludec
Participants will receive insulin degludec SC
Authors
Cindy Bredefeld, Anna Chang, Serge Jabbour, Betsy Palal, Thomas Blevins, Satish Garg, Joanna T. Van, Ajay Chaudhuri, Thomas Cunningham Jones, Cindy H. T. Pau, Alan Glenn Wynne, Jean Young Park, Peter Edward Bressler, Samer Nakhle, Rizwana H Mohseni, Kristin Castorino, Carl D Vance, Paul Carlton Norwood, MICHAEL A DEMPSEY, Sam Lerman, Julio Rosenstock, Sumana Gangi, Frances Eileen Broyles, Donald Franklin Gardner, Lenita Hanson, Ralph Joseph Duda, Senan Sultan, Antonio Pinero-Pilona, Ruth S Weinstock, Anuj Bhargava, Heidi Chamberlain Shea, Raveendra Kodur, Seiya Hagiwara, Yukari Shimizu, Masayuki Noritake, Katsushige Abe, Silvana Ernestina Solis, Silvia Ines Orio, Hien Tran, hikaru kamoshima, Marcos Alejandro Mayer, Lucrecia Nardone, Pablo Rene Costanzo, Edward Franek, Federico C. Perez Manghi, Martha Gomez-Cuellar, Jan Truban, Shuji Nakamura, Hideo Takahashi, Dalibor Sosovec, Beata Matyjaszek-Matuszek, Masahiko Takai, Horng-Yih Ou, Masae Minami, Kai-Jen Tien, Naoyuki Yamamoto, Sonia Griselda Hermida, Piyush H Deasi, Anna Modzelewska, Monika Lukaszewicz, Ewa Skokowska, Pedro Rosario Fabian Calella, Angel Luis Comulada-Rivera, Katarzyna Klodawska, Maria Eugenia Valdez, Joanna Mirocka, Elizabeth Gelersztein, Amir Ali Hassan, Dorota Mlodawska-Choluj, Leonardo Pablo Serra, Miriam Teplanova, José Osvaldo Fretes, Patricia Mabel Castaño, Janusz Gumprecht, Cecilia M. Luquez, Shih-Te Tu, Chii-Min Hwu, Takeshi Osonoi, I-Te Lee, Chien-Ning Huang, Shizuka Kaneko, Hideaki Jinnouchi, Vishnupriya Rao Paturi, Yukiko Onishi, Takahiro Tosaki, Anastasios Manessis, Malgorzata Arciszewska
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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