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NCT05823948
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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