Type 2 Diabetes
Conditions
Interventions
-Drug: LY3209590
Administered SC
-Drug: Insulin Degludec
Administered SC
Study Arms
-Experimental: LY3209590
Participants will be given LY3209590 subcutaneously (SC).
Intervention: Drug: LY320
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Have been diagnosed with Type 2 diabetes according to the World Health Organization (WHO) criteria treated with basal insulin -Are receiving >=10 units of basal insulin per day and <=110 units per day at screening -Have HbA1c value of 6.5% - 10% inclusive, at screening -Have a Body mass index (BMI) less than or equal to 45 kilogram/square meter (kg/m2) -Have been treated with one of the following stable insulin regimens at least 90 days prior to screening: -once daily U100 or U200 of insulin degludec -once daily U100 or U300 of insulin glargine -once or twice daily U100 of insulin detemir, or -once or twice daily human insulin NPH -acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following: -dipeptidyl peptidase (DPP-4) IV inhibitors -SGLT2 inhibitors -metformin -alphaglucosidase inhibitors or, -Glucagon-Like Peptide-1 (GLP-1) receptor agonists -Participants must be willing to stay on stable dose throughout the study
Exclusion criteria
Exclusion criteria: -Have Type 1 diabetes mellitus -Have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except Nonalcoholic Fatty Liver Disease (NAFLD) -Estimated glomerular filtration rate (eGFR) <20 milliliters/minute/1.73 square meter (m2) -Have active or untreated malignancy -Are pregnant -Have a significant weight gain or loss the past 3 months -Have received anytime in the past 6 months, any of the following insulin therapies: -prandial insulin -insulin mixtures -inhaled insulin -U-500 insulin, or -continuous subcutaneous insulin infusion therapy -Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months: -acute myocardial infarctions -cerebrovascular accident (stroke), or -coronary bypass surgery -Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ] Change from Baseline in HbA1c of LY3209590 compared to insulin degludec on glycemic control in participants with type 2 diabetes currently on basal insulin. | — |
Countries
Argentina, Hungary, Japan, Korea, Republic of, Poland, Puerto Rico, Slovakia, Spain, Taiwan, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed