Efficacy and Safety of LY3209590 Compared with Daily Insulin Glargine in Adults with Type 2 Diabetes on Multiple Daily Injections
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2021-005878-25-DE
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 670
•Are =18 years of age, at screening (Visit 1), per local regulations.
•Have a diagnosis of type 2 diabetes mellitus (T2D) treated with basal insulin and at least two injections of prandial insulin per day
•Are receiving =10 units of basal insulin per day at screening (Visit 1)
•Are receiving less than or equal to 2 units/kg/day of total daily insulin at screening (Visit 1)
•Have an HbA1c value of 7.0% to 10% inclusive at screening
•Have been treated with a stable regimen of one of the following basal insulins for at least 90 days
•once daily U100 or U200 insulin degludec; once daily U100 or U300 insulin glargine, once or twice daily U100 insulin detemir (Levemir), or once or twice daily human insulin Neutral Protamine Hagedorn
•Have been treated with at least twice daily dosing of any of the following for at least 90 days. One dose of prandial insulin must occur prior to the evening meal. Lispro (U100 and U200), Lispro-aabc (U100 or U200), Aspart (U100; including Fiasp and Novolog), Glulisine (U100), Regular insulin (U100)
•Acceptable noninsulin diabetes therapies may include 0 to up to 3 of the following with a stable dose for at least 90 days:
•dipeptidyl peptidase IV inhibitors, sodium-glucose co-transporter-2 inhibitors, biguanides (e.g., metformin), or glucagon-like peptide-1 receptor agonists.
•Have a BMI =45 kg/m2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 603
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 67
• Have a diagnosis of type 1 diabetes mellitus or latent autoimmune diabetes, or specific type of diabetes other than T2D
• Are currently receiving any of the following insulin therapies (outside of pregnancy) anytime in the past 90 days except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks: Insulin mixtures, Affreza (inhaled regular human insulin), continuous subcutaneous insulin infusion therapy, Regular insulin U500
• Have received any of the following nonallowed diabetes medication within prior 90 days: glinides, sulfonylureas, pramlintide, alpha-glucosidase inhibitors or thiazolidinediones
• Have a history of greater than 1 episode of ketoacidosis or hyperosmolar state/coma requiring hospitalization in the 6 months prior to screening
• Have had any episodes of severe hypoglycemia within the 6 months prior to screening
• Have hypoglycemia unawareness in the opinion of the investigator
• Anticipates making change in personal CGM or FGM use (e.g., initiation, stopping, changing device) during the study
• Hepatic: Have acute or chronic hepatitis, cirrhosis, or signs or symptoms of any other liver disease, except nonalcoholic fatty liver(NAFLD), or have elevated liver enzyme measurements
• Oncologic: Have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
• Hematologic: Have had a blood transfusion or severe blood loss within 90 days prior to Visit 1, Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
• Cardiac: Have had New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months prior to screening: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery.
• Gastrointestinal: Have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery, for example Lap-Band, or sleeve gastrectomy within 1 year prior to screening. Have presence of clinically significant gastroparesis in the opinion of the investigator
• Renal: Have a history of renal transplantation, are currently receiving renal dialysis, or have an estimated glomerular filtration rate <30 mL/min/1.73 m2, as determined by the central laboratory
• Other: Have any other serious disease or condition (for example, known drug or alcohol abuse or psychiatric disorder) that, in the opinion of the investigator, would pose a significant risk to the study participant, or preclude the study participant from following and completing the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method