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A Study Using Flash Glucose Measurements for a New Once-weekly Insulin (Insulin Icodec) in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 9)
Sponsor: Novo Nordisk A/S
Summary
This study looks at how a person with type 2 diabetes can be treated with insulin icodec and a flash glucose monitor (a small sensor inserted under the skin to measure blood sugar all the time). The study will look at how well insulin icodec controls blood sugar when used in combination with a flash glucose monitor. Participants will get insulin icodec that they have to inject once a week on the same day of the week. The insulin will be injected with a needle in a skin fold in the thigh, upper arm, or stomach. The study will last for about 8 months. Participants will have to wear a flash glucose monitor throughout the study. This is a sensor that fits on arm. Participants will be asked to use a commercially available app called LibreView to allow team to view flash glucose monitor data. Participants will get a study phone to scan the flash glucose monitor 4 times daily and they will be able to see all of the flash glucose monitor data during the study. Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
Official title: A Study to Evaluate Flash Glucose Monitoring Based Titration of Once-weekly Insulin Icodec in Insulin-naïve Participants With Type 2 Diabetes
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2023-04-11
Completion Date
2024-04-11
Last Updated
2026-04-30
Healthy Volunteers
No
Conditions
Interventions
Insulin Icodec
Participants will receive insulin icodec once-weekly subcutaneously into the thigh, upper arm or abdomen.
Locations (20)
Desert Oasis Hlthcr Med Group
Palm Springs, California, United States
Clinical Trials Research_Sacramento_0
Sacramento, California, United States
San Diego Family Care
San Diego, California, United States
Mills-Peninsula Hlth Services
San Mateo, California, United States
Florida Inst For Clin Res LLC
Orlando, Florida, United States
Metabolic Research Institute Inc
West Palm Beach, Florida, United States
East West Med Res Inst
Honolulu, Hawaii, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Palm Research Center Inc-Vegas
Las Vegas, Nevada, United States
Accellacare_NC
Wilmington, North Carolina, United States
Diabetes & Endocrinology Asso
Canton, Ohio, United States
AM Diabetes And Endocrinology
Bartlett, Tennessee, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Velocity Clin Res, Dallas
Dallas, Texas, United States
UT Southwestern Med Cntr
Dallas, Texas, United States
Fmc Science, Llc
Lampasas, Texas, United States
Clinical Trials of Texas Inc
San Antonio, Texas, United States
Northeast Clinical Research of San Antonio
San Antonio, Texas, United States
Chrysalis Clinical Research
St. George, Utah, United States