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)
- Conditions
- T2DType 2 Diabetes
- Interventions
- Registration Number
- NCT05662332
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 795
- 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.
- 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%.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Insulin Efsitora Alfa Insulin Efsitora Alfa Participants will receive insulin efsitora alfa subcutaneously (SC) once weekly. Insulin Glargine Insulin Glargine Participants will receive insulin glargine SC once daily.
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 52 Demonstrate noninferiority of insulin efsitora alfa compared to insulin glargine
- Secondary Outcome Measures
Name Time Method Change from Baseline in HbA1c Baseline, Week 52 Demonstrate superiority of insulin efsitora alfa compared to insulin glargine
Level 2 and 3 Nocturnal Hypoglycemia Event Rate of Composite and Incidence Week 52 Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.
Change from Baseline in Body Weight Baseline, Week 52 Change from Baseline in Treatment Experience in Diabetes Injection Device Experience Questionnaire (DID-EQ) in Device Characteristics Baseline, Week 52 DID-EQ assesses participants' perceptions of non-insulin diabetes injection delivery systems for type 2 diabetes.
Change from Baseline in Fasting Glucose Baseline, Week 52 Change from baseline in fasting glucose measured by self-monitoring blood glucose (SMBG)
Level 2 and 3 Hypoglycemia Event Rate of Composite and Incidence Week 52 Incidence and rate of composite of Level 2 and 3 hypoglycemia events during the treatment period.
Change from Baseline in Diabetes Treatment Satisfaction Questionnaire-Status Version (DTSQ) in Overall Treatment Satisfaction Baseline, Week 52 DTSQ assesses the overall treatment satisfaction and perceived frequency of hyperglycemia and hypoglycemia.
Change from Baseline in Treatment-Related Impact Measure - Diabetes (TRIM-D) Baseline, Week 52 TRIM-D assesses the impact of diabetes treatment on participants' functioning and well-being across available diabetes treatments.
Change from Baseline in Treatment Experience in Simplicity of Diabetes Treatment Questionnaire (SIM-Q) in Overall Simplicity and Complexity Baseline, Week 52 SIM-Q assess the simplicity and complexity of treatment for type 2 diabetes (single medication).
Trial Locations
- Locations (70)
Cahaba Research
🇺🇸Birmingham, Alabama, United States
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
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