A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1)
Completed · Phase 3
Conditions studied: Type 2 Diabetes, T2D
In brief
The main purpose of this study is to determine the efficacy and safety of insulin efsitora alfa (LY3209590) administered weekly using a fixed dose escalation compared to insulin glargine in adults with type 2 diabetes (T2D) who are starting basal insulin therapy for the first time.
Key facts
- Study ID
- NCT05662332
- Run by
- Eli Lilly and Company
- People needed
- 795
- Starts
- 2023-01-14
- Expected to finish
- 2024-07-19
- Last updated by the study team
- 2025-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a diagnosis of T2D according to the World Health Organization criteria.
- Have an HbA1c of 7.0% to 10.0%, inclusive, at screening.
- Are on a stable treatment of at least 1 antihyperglycemic medication, for at least 3 months prior to screening, and willing to continue the stable treatment for the duration of the study.
- Are insulin naive
- Exceptions:
- short-term insulin treatment for a maximum of 14 days, prior to screening, and
- prior insulin treatment for gestational diabetes.
You may not qualify if…
- Have a diagnosis of type 1 diabetes (T1D), latent autoimmune diabetes, or specific type of diabetes other than T2D, for example, monogenic diabetes, diseases of the exocrine pancreas, or drug induced or chemical-induced diabetes.
- Have a history of >1 episode of ketoacidosis or hyperosmolar state or coma requiring hospitalization within 6 months prior to screening.
- Have had severe hypoglycemia episodes within 6 months prior to screening.
- Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- Have had New York Heart Association Class IV heart failure or any of these cardiovascular conditions within 3 months prior to screening
- acute myocardial infarction
- cerebrovascular accident (stroke), or
- coronary bypass surgery.
- Have had gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening
- Have had significant weight gain or loss within 3 months prior to screening, for example, ≥5%.
Where it is running
- Syed Research Consultants Llc — Sheffield, Alabama, United States
- AMCR Institute — Escondido, California, United States
- Velocity Clinical Research, Gardena — Gardena, California, United States
- National Research Institute - Huntington Park — Huntington Park, California, United States
- National Research Institute - Wilshire — Los Angeles, California, United States
- Diabetes Associates Medical Group — Orange, California, United States
- Encompass Clinical Research — Spring Valley, California, United States
- Millennium Clinical Trials — Thousand Oaks, California, United States
- University Clinical Investigators, Inc. — Tustin, California, United States
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
- Chase Medical Research, LLC — Waterbury, Connecticut, United States
- Clinical Research of West Florida, Inc. (Clearwater) — Clearwater, Florida, United States
- Suncoast Research Group — Miami, Florida, United States
- Clinical Research of West Florida — Tampa, Florida, United States
- Center for Advanced Research & Education — Gainesville, Georgia, United States
- Pacific Diabetes & Endocrine Center — Honolulu, Hawaii, United States
- Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative — Springfield, Illinois, United States
- American Health Network of Indiana, LLC - Franklin — Franklin, Indiana, United States
- American Health Network of Indiana, LLC - Muncie — Muncie, Indiana, United States
- Iowa Diabetes and Endocrinology Research Center — West Des Moines, Iowa, United States
- Arcturus Healthcare , PLC, Troy Internal Medicine Research Division — Troy, Michigan, United States
- Clinvest Research LLC — Springfield, Missouri, United States
- University Of Nebraska Medical Center — Omaha, Nebraska, United States
- Cahaba Research — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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