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About
The reason for this study is to see if the study drug insulin efsitora alfa (LY3209590) is safe and effective in participants with Type 2 diabetes that have already been treated with basal insulin. The study consists of a 3-week screening/lead-in period, a 78-week treatment period and a 5-week safety follow-up period. The study will last up to 86 weeks.
Enrollment
Sex
Ages
Volunteers
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:
acceptable non insulin glucose lowering therapies may include 0 to up to 3 of the following:
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:
Have had any of New York Heart Association Class IV heart failure or any of the following CV conditions in the past 3 months:
Gastrointestinal: have undergone gastric bypass (bariatric) surgery, restrictive bariatric surgery (Lap-Band) or sleeve gastrectomy within 1 year prior to screening
Primary purpose
Allocation
Interventional model
Masking
986 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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