A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)
A Phase 3, Multicenter, Randomized, Parallel-Design, Open-Label Trial to Evaluate the Efficacy and Safety of LY3209590 Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin (QWINT-3)
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.
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
Troy, Michigan 48098, United States
Minneapolis, Minnesota 55416, United States
Ciudad Autónoma de Buenos Aire, Buenos Aires 1056, Argentina
Ciudad Autonoma de Buenos Aire, Buenos Air C1405BUB, Argentina
Ciudad Autónoma de Buenos Aire, Buenos Air C1023AAB, Argentina
CABA, Ciudad Autónoma de Buenos Aire 1204, Argentina
Capital, Córdoba Province X5008HHW, Argentina
Godoy Cruz, Mendoza Province M5501ARP, Argentina
Ciudad Autónoma de Buenos Aire, C1440AAD, Argentina
Kamakura-shi, Kanagawa 247-0056, Japan
Yamato-shi, Kanagawa 242-0004, Japan
Saitama-shi, Saitama 336-0967, Japan
Chuo Ku, Tokyo 103-0027, Japan
Chuo-ku, Tokyo 103-0002, Japan
Chuo-ku, Tokyo 103-0028, Japan
Chuo-ku, Tokyo 104-0031, Japan
Ruda Śląska, Silesian Voivodeship 41-709, Poland
Lodz, Łódź Voivodeship 90338, Poland