A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
A Phase 2, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of LY3209590 in Study Participants With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin
2 other identifiers
interventional
399
3 countries
44
Brief Summary
The reason for this study is to see if the study drug LY3209590 is safe and effective in participants with type 2 diabetes that have already been treated with basal insulin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 type-2-diabetes-mellitus
Started Nov 2018
44 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
November 2, 2018
CompletedFirst Posted
Study publicly available on registry
November 9, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 18, 2020
CompletedResults Posted
Study results publicly available
March 8, 2021
CompletedMarch 8, 2021
March 1, 2020
1.3 years
November 2, 2018
February 12, 2021
February 12, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HbA1c
HbA1c is the glycosylated fraction of haemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Change from baseline in HbA1c was analysed by mixed model repeated measures (MMRM) including fixed effects of treatment, stratification factors (country, BMI group \[\> 30 or ≤ 30\], sulfonylureas use at study entry), visit and treatment by visit interaction and baseline HbA1c as the covariate.
Baseline, Week 32
Secondary Outcomes (7)
Change From Baseline in HbA1c Compared to Insulin Degludec
Baseline, Week 32
Change From Baseline in Fasting Glucose
Baseline, Week 32
Change From Baseline in Insulin Dose (LY3209590)
Week 1, Week 32
Change From Baseline in Insulin Dose (Insulin Degludec)
Baseline, Week 32
Rate of Total Documented Symptomatic Hypoglycemia
Baseline through week 32
- +2 more secondary outcomes
Study Arms (3)
LY3209590 Algorithm 1
EXPERIMENTALParticipants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous (SC) injection. Dose titration was done to maintain fasting blood glucose of \<140 milligram per deciliter (mg/dL).
LY3209590 Algorithm 2
EXPERIMENTALParticipants received loading dose followed by weekly dose of LY3209590 based on the prior randomization basal insulin dose for a period of 32 weeks by subcutaneous injection. Dose titration was done to maintain fasting blood glucose of \<120 mg/dL.
Insulin Degludec
ACTIVE COMPARATORParticipants received same dose of Degludec as the total basal insulin dose already administered prior to randomization. Dose was titrated to maintain fasting blood glucose of ≤100 mg/dL to achieve glycemic goal of HbA1C \<7%.
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes mellitus according to the World Health Organization (WHO) criteria treated with basal insulin and up to 3 of the following oral antihyperglycemic medication (OAM):
- dipeptidyl peptidase-4 (DPP-4) inhibitors
- sodium-glucose cotransporter (SGLT-2) inhibitors
- biguanides
- alpha-glucosidase inhibitors
- sulfonlyureas
- HbA1c value of 6.5% to 10%, inclusive
- Body mass index (BMI) between 20 and 45 kilograms per meter squared (kg/m2), inclusive
You may not qualify if:
- Type 1 diabetes mellitus or latent autoimmune diabetes
- Any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening
- Any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke)
- Acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease
- Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 m2
- Active or untreated malignancy
- Chronic (\>14 days) systemic glucocorticoid therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Central Research Associates, Inc.
Birmingham, Alabama, 35205, United States
Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
John Muir Physician Network Clinical Research Center
Concord, California, 94520, United States
AMCR Institute INC
Escondido, California, 92025, United States
Valley Endocrine, Fresno
Fresno, California, 93720, United States
Marin Endocrine Associates
Greenbrae, California, 94904, United States
National Research Institute
Huntington Park, California, 90255, United States
First Valley Medical Group
Lancaster, California, 93534, United States
National Research Institute
Los Angeles, California, 90057, United States
University Clinical Investigators, Inc.
Tustin, California, 92780, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
ALL Medical Research, LLC
Cooper City, Florida, 33024, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
Metabolic Research Institute Inc.
West Palm Beach, Florida, 33401, United States
East West Medical Institute
Honolulu, Hawaii, 96814, United States
Elite Clinical Trials LLLP
Blackfoot, Idaho, 83221, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, 83404, United States
Iderc, P.L.C.
West Des Moines, Iowa, 50265, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606, United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852, United States
NECCR PrimaCare Research, LLC
Fall River, Massachusetts, 02721, United States
Palm Research Center
Las Vegas, Nevada, 89128, United States
Palm Research Center
Las Vegas, Nevada, 89148, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, 03063, United States
Metrolina Internal Medicine, P.A.
Charlotte, North Carolina, 28207, United States
Intend Research
Norman, Oklahoma, 73069, United States
The Corvallis Clinic P.C.
Corvallis, Oregon, 97330, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Preferred Primary Care Physicians - Jacob Murphy Lane
Uniontown, Pennsylvania, 15401, United States
Internal Medicine Associates of Anderson
Anderson, South Carolina, 29621, United States
The Research Center of the Upstate
Mauldin, South Carolina, 29662, United States
Texas Diabetes and Endocrinology
Austin, Texas, 78731-4309, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Confluence Health Clinical Research Department
Wenatchee, Washington, 98801, United States
Hospital Universitario UANL
Monterrey, Nuevo León, 64460, Mexico
Investigacion en Salud y Metabolismo S.C
Chihuahua City, 31217, Mexico
Advanced Clinical Research, LLC
Bayamón, PR, 00961, Puerto Rico
Manati Center for Clinical Research Inc
Manatí, PR, 00674, Puerto Rico
GCM Medical Group PSC
San Juan, PR, 00917, Puerto Rico
Martha Gomez Cuellar M.D.
San Juan, PR, 00921, Puerto Rico
Centro de Endocrinologia del Este
Yabucoa, 00767, Puerto Rico
Related Publications (1)
Frias J, Chien J, Zhang Q, Chigutsa E, Landschulz W, Syring K, Wullenweber P, Haupt A, Kazda C. Safety and efficacy of once-weekly basal insulin Fc in people with type 2 diabetes previously treated with basal insulin: a multicentre, open-label, randomised, phase 2 study. Lancet Diabetes Endocrinol. 2023 Mar;11(3):158-168. doi: 10.1016/S2213-8587(22)00388-6. Epub 2023 Feb 6.
PMID: 36758572DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
November 2, 2018
First Posted
November 9, 2018
Study Start
November 15, 2018
Primary Completion
February 18, 2020
Study Completion
February 18, 2020
Last Updated
March 8, 2021
Results First Posted
March 8, 2021
Record last verified: 2020-03
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.