A Study of LY3209590 in Participants With Type 1 Diabetes
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
3 other identifiers
interventional
266
5 countries
54
Brief Summary
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 1 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2020
Shorter than P25 for phase_2
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2020
CompletedFirst Posted
Study publicly available on registry
June 29, 2020
CompletedStudy Start
First participant enrolled
July 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedResults Posted
Study results publicly available
October 27, 2022
CompletedOctober 27, 2022
September 1, 2022
1.2 years
June 26, 2020
September 29, 2022
September 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of haemoglobin A. It is measured to identify average blood glucose concentration over prolonged periods of time. Least squares (LS) mean change from baseline was analysed by mixed model repeated measures (MMRM) model with treatment, country, visit, and treatment by visit interaction as fixed effects and the baseline HbA1c as a covariate.
Baseline, Week 26
Secondary Outcomes (4)
Change From Baseline in Fasting Serum Glucose
Baseline, Week 26
Change From Baseline in Bolus Insulin Dose
Baseline, Week 26
Rate of Documented Hypoglycemia
Baseline through Week 26
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590
Week 26
Study Arms (3)
LY3209590 Algorithm 1 (Paper)
EXPERIMENTALAlgorithm 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).
LY3209590 Algorithm 2 (Digital)
EXPERIMENTALAlgorithm 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.
Insulin Degludec
ACTIVE COMPARATORInsulin 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening
- Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
- Have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
- Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
- Have an estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m²
- Have active or untreated cancer
- Are receiving chronic (\>14 days) systemic glucocorticoid therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
Valley Endocrine, Fresno
Fresno, California, 93720, United States
Coastal Metabolic Research Centre
Ventura, California, 93003, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Denver Endocrinology, Diabetes & Thyroid Center
Englewood, Colorado, 80113, United States
East Coast Institute for Research at The Jones Center
Jacksonville, Florida, 32204, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, 34652, United States
Bayside Clinical Research, LLC
New Port Richey, Florida, 34655, United States
Metabolic Research Institute, Inc.
West Palm Beach, Florida, 33401, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
East Coast Institute for Research at The Jones Center
Macon, Georgia, 31210, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50265, United States
Diabetes and Metabolism Associates, APMC
Metairie, Louisiana, 70006, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128, United States
Southern Nh Diabetes and Endocrinology
Nashua, New Hampshire, 03060, United States
Suny Health Science Center at Syracuse
Syracuse, New York, 13210, United States
Lucas Research, Inc.
Morehead City, North Carolina, 28557, United States
PMG Research of Piedmont Healthcare
Statesville, North Carolina, 28625, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Intend Research, LLC
Norman, Oklahoma, 73069, United States
Holston Medical Group
Bristol, Tennessee, 37620, United States
Univ Diab & Endo Consult
Chattanooga, Tennessee, 37411, United States
Texas Diabetes & Endocrinology, P.A.
Austin, Texas, 78731-4309, United States
Research Institute of Dallas
Dallas, Texas, 75231, United States
Diabetes and Thyroid Center of Fort Worth
Fort Worth, Texas, 76132, United States
Endocrine and Psychiatry Center
Houston, Texas, 77095, United States
Southern Endocrinology Associates
Mesquite, Texas, 75149, United States
Texas Diabetes & Endocrinology, P.A.
Round Rock, Texas, 78681, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Universitätsklinikum Graz
Graz, Styria, 8036, Austria
Klinik Landstraße
Vienna, 1030, Austria
Zentrum für klinische Studien Dr Hanusch Gmbh
Vienna, 1060, Austria
Praxis Dr. Jörg Lüdemann
Falkensee, Brandenburg, 14612, Germany
InnoDiab Forschung Gmbh
Essen, North Rhine-Westphalia, 45136, Germany
Institut für Diabetesforschung GmbH Münster
Münster, North Rhine-Westphalia, 48145, Germany
Practice Dr.med. Denger and Dr.med. Pfitzner
Friedrichsthal, Saarland, 66299, Germany
Zentrum für klinische Studien
Saint Ingbert, Saarland, 66386, Germany
SMO.MD GmbH
Magdeburg, Saxony-Anhalt, 39120, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Diabeteszentrum Hamburg West
Hamburg, 22607, Germany
Dr Altagracia Aurora Alcantara Gonzalez
Bayamón, PR, 00956, Puerto Rico
Advanced Clinical Research, LLC
Bayamón, PR, 00961, Puerto Rico
Martha Gomez Cuellar M.D.
San Juan, PR, 00921, Puerto Rico
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Hospital Quiron Infanta Luisa
Seville, Andalusia, 41010, Spain
Hospital Universitario de La Ribera
Alzira, Valencia, 46600, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, 15006, Spain
Centro Periférico de Especialidades Bola Azul
Almería, 04009, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología
Seville, 41003, Spain
Hospital Universitario Virgen Macarena
Seville, 41007, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was initially designed as 3 arms: LY3209590 Algorithm 1 (Paper), LY3209590 Algorithm 2 (Digital), and Insulin Degludec. However, it was amended to terminate the "LY3209590 Algorithm 2 (Digital)" arm during early enrollment phase due to technical issues with data entry. Thus, this arm was excluded from the outcome measure analyses, but safety data was analysed and reported.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2020
First Posted
June 29, 2020
Study Start
July 6, 2020
Primary Completion
October 1, 2021
Study Completion
October 1, 2021
Last Updated
October 27, 2022
Results First Posted
October 27, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.