A Study of Insulin Efsitora Alfa (LY3209590) as a Weekly Basal Insulin Compared to Insulin Glargine in Adult Participants With Type 2 Diabetes on Multiple Daily Injections
- Conditions
- Type 2 DiabetesType 2 Diabetes Treated With Insulin
- Registration Number
- NCT05462756
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Have a diagnosis of T2D according to the world health organization (WHO) criteria,<br> currently treated with basal insulin and at least 2 injections of prandial insulin<br> per day.<br><br> - Are receiving =10 units of total basal insulin per day at screening.<br><br> - Are receiving =2 units/kilogram/day of total daily insulin at screening<br><br> - Have an HbA1c value of 7.0% to 10%, inclusive, as determined by the central<br> laboratory at screening<br><br> - Have been treated with a stable regimen of one of the following basal insulins used<br> according to local product label with or without noninsulin diabetes therapy for at<br> least 90 days prior to screening<br><br> - once daily U-100 or U-200 insulin degludec<br><br> - once daily U-100 or U-300 insulin glargine<br><br> - once or twice daily U-100 insulin detemir or<br><br> - once or twice daily human insulin Neutral Protamine Hagedorn<br><br> - Have been treated with at least twice daily dosing of one of the following insulins<br> used according to local product label for at least 90 days prior to screening. One<br> dose of prandial insulin must occur at the evening meal.<br><br> - Insulin lispro-aabc<br><br> - Insulin lispro (U-100 and U-200)s, IN], U-100 or U200)<br><br> - Insulin aspart (U-100)<br><br> - Insulin glulisine (U-100), or<br><br> - Regular insulin (U-100)<br><br> - Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following<br> with a stable dose for at least 90 days prior to screening<br><br> - dipeptidyl peptidase IV inhibitors<br><br> - sodium-glucose co-transporter-2 inhibitors<br><br> - biguanides (for example, metformin), or<br><br> - glucagon-like peptide-1 receptor agonists Note: All noninsulin diabetes<br> therapies must be used in accordance with the corresponding local product label<br> at the time of screening, and participants should be willing to continue stable<br> dosing throughout the study<br><br> - Have a body mass index =45 kilogram/square meter (kg/m²)<br><br>Exclusion Criteria:<br><br> - Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or<br> specific type of diabetes other than T2D (for example, monogenic diabetes, diseases<br> of the exocrine pancreas, drug-induced or chemical-induced diabetes).<br><br> - Are currently receiving any of the following insulin therapies anytime in the past<br> 90 days:<br><br> - insulin mixtures<br><br> - insulin human, inhalation powder, or<br><br> - continuous subcutaneous insulin infusion therapy, or<br><br> - regular insulin U-500<br><br> - Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma<br> requiring hospitalization in the 6 months prior to screening<br><br> - Have had any episodes of severe hypoglycemia, defined as requiring assistance due to<br> neurologically disabling hypoglycemia, within the 6 months prior to screening<br><br> - Have hypoglycemia unawareness in the opinion of the investigator<br><br> - Anticipate making changes in personal CGM or flash glucose monitoring (FGM) use (for<br> example, initiation, stopping, or changing device) during the study.<br><br> - Have had New York Heart Association Class IV heart failure or any of the following<br> cardiovascular conditions in the past 3 months prior to screening: acute myocardial<br> infarction, cerebrovascular accident (stroke), or coronary bypass surgery.<br><br> - Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, or<br> sleeve gastrectomy within 1 year prior to screening
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from Baseline in HbA1c
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving HbA1c <7% without Nocturnal Hypoglycemia;Nocturnal Hypoglycemia Event Rate;Change from Baseline in Fasting Glucose;Time in Glucose Range;Time in Hypoglycemia Range;Time in Hyperglycemia Range;Glucose Variability;Basal Insulin Dose;Bolus Insulin Dose;Total Insulin Dose;Basal Insulin Dose to Total Insulin Dose Ratio;Hypoglycemia Event Rate;Change from Baseline in Body Weight;Treatment Experience for Diabetes Injection Device at Week 26 - Experience Questionnaire (DID-EQ)