A Phase 2, Randomized, Parallel, Open-Label Comparator-Controlled Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 1 Diabetes Mellitus Previously Treated With Multiple Daily Injection Therapy
Who is this study for? Children and adolescent patients with type 1 diabetes
What treatments are being studied? LY3209590
Status: Completed
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year
• Participants must have been using multiple daily injections without interruption for at least 3 months
• Participants must have HbA1c values of 5.6% to 9.5%, inclusive
• Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²)
Locations
United States
California
John Muir Physician Network Clinical Research Center
Concord
Valley Endocrine, Fresno
Fresno
Coastal Metabolic Research Centre
Ventura
Colorado
Barbara Davis Center for Childhood Diabetes
Aurora
Denver Endocrinology, Diabetes & Thyroid Center
Englewood
Florida
East Coast Institute for Research at The Jones Center
Jacksonville
Bayside Clinical Research, LLC
New Port Richey
Sun Coast Clinical Research, Inc
New Port Richey
Metabolic Research Institute, Inc.
West Palm Beach
Georgia
Atlanta Diabetes Associates
Atlanta
East Coast Institute for Research at The Jones Center
Macon
Endocrine Research Solutions, Inc.
Roswell
Iowa
Iowa Diabetes and Endocrinology Research Center
West Des Moines
Idaho
Rocky Mountain Clinical Research
Idaho Falls
Louisiana
Diabetes and Metabolism Associates, APMC
Metairie
Maryland
Endocrine and Metabolic Consultants
Rockville
North Carolina
Lucas Research, Inc.
Morehead City
PMG Research of Piedmont Healthcare
Statesville
PMG Research of Wilmington
Wilmington
New Hampshire
Southern Nh Diabetes and Endocrinology
Nashua
Nevada
Palm Research Center Tenaya
Las Vegas
New York
Suny Health Science Center at Syracuse
Syracuse
Oklahoma
Intend Research, LLC
Norman
Tennessee
Holston Medical Group
Bristol
Univ Diab & Endo Consult
Chattanooga
Texas
Texas Diabetes & Endocrinology, P.A.
Austin
Research Institute of Dallas
Dallas
Diabetes and Thyroid Center of Fort Worth
Fort Worth
Endocrine and Psychiatry Center
Houston
Southern Endocrinology Associates
Mesquite
Texas Diabetes & Endocrinology, P.A.
Round Rock
Consano Clinical Research, LLC
Shavano Park
Washington
Rainier Clinical Research Center
Renton
Other Locations
Austria
Universitätsklinikum Graz
Graz
Klinik Landstraße
Vienna
Zentrum für klinische Studien Dr Hanusch Gmbh
Wien
Germany
InnoDiab Forschung Gmbh
Essen
Praxis Dr. Jörg Lüdemann
Falkensee
Practice Dr.med. Denger and Dr.med. Pfitzner
Friedrichsthal
Diabeteszentrum Hamburg West
Hamburg
SMO.MD GmbH
Magdeburg
Institut für Diabetesforschung GmbH Münster
Münster
RED-Institut GmbH
Oldenburg
Zentrum für klinische Studien
Saint Ingbert
Puerto Rico
Advanced Clinical Research, LLC
Bayamon
Dr Altagracia Aurora Alcantara Gonzalez
Bayamon
Martha Gomez Cuellar M.D.
San Juan
Spain
Centro Periférico de Especialidades Bola Azul
Almeria
Hospital Universitario de La Ribera
Alzira
Complexo Hospitalario Universitario A Coruña, CHUAC
La Coruña
Hospital Universitario Virgen de la Victoria
Malaga
Clínica nuevas Tecnologías en Diabetes y Endocrinología
Sevilla
Hospital Quiron Infanta Luisa
Sevilla
Hospital Universitario Virgen Macarena
Sevilla
Time Frame
Start Date: 2020-07-06
Completion Date: 2021-10-01
Participants
Target number of participants: 266
Treatments
Experimental: LY3209590 Algorithm 1 (Paper)
Algorithm 1 is a paper-based algorithm where dose adjustments were manually determined by the investigator based on fasting glucose and hypoglycemia data. LY3209590 was provided in a 20 milligram (mg) vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by subcutaneous (SC) injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 milligrams per deciliter (mg/dL).
Experimental: LY3209590 Algorithm 2 (Digital)
Algorithm 2 is a computer-based algorithm to determine dose adjustments. LY3209590 was provided in a 20 mg vial of reconstitutable lyophilized powder. Participants received individualized LY3209590 loading dose based on the basal insulin dose prior randomization and baseline fasting glucose by SC injection on day 1 followed by weekly adjustments for the first 12 weeks, then every 4 weeks, of a 26-week treatment period, to achieve target fasting glucose of \<=100 mg/dL.~As per protocol amendment (d) approved on 28-Oct-2020, this arm was terminated during the early enrollment phase due to technical issues with data entry.
Active_comparator: Insulin Degludec
Insulin degludec was provided as 100 units/milliliter (U/mL) in a prefilled pen. Participants received individually adjusted doses once daily by SC injection with a starting dose same as basal insulin dose prior randomization, during the 26-week treatment period, to achieve target fasting blood glucose of \<=100 mg/dL.
Authors
Simon Vidal, Lori Gerard, Rakesh Patel, Anna R Chang, Bruce Bode, Betsy Palal, Satish Garg, Angel Luis Comulada-Rivera, Ronald H Chochinov, Lisa Connery, Barry Scot Horowitz, David Huffman, Thomas Cunningham Jones, Altagracia A Alcantara-Gonzalez, Harold Miller, Ryan Kennedy, Leslie J Klaff, Samer Nakhle, Luis Casaubon, Carl D Vance, MICHAEL A DEMPSEY, Kathryn Jean Lucas, John C Parker, Charalambos Demetri, Sumana Gangi, Stephen Aronoff, John Chip H. Reed, Anjanette Tan, Robert Jeffrey Silver, Kerem Ozer, Wendell Miers, Ruth S Weinstock, Timothy S. Bailey, Anuj Bhargava, Jörg Lüdemann, Dominik Dahl, Ludger Rose, Hans-Peter Kempe, Paul Carlton Norwood, Halis Kaan Akturk, Pedro Mezquita-Raya, Bernhard Ludvik, Harald Sourij
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company