NCT05823948CompletedPhase 3
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)
A Study to Evaluate Flash Glucose Monitoring Based Titration of Once-weekly Insulin Icodec in Insulin-naïve Participants With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 51 (actual)
- First submitted
- 9 Apr 2023
- Start date
- 11 Apr 2023
- Primary completion date
- 6 Mar 2024
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Type 2 diabetes
- NCT number
- NCT05823948
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 51
- From 11 Apr 2023 to the primary completion date, 6 Mar 2024
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any episodes of diabetic ketoacidosis within 90 days before screening as declared by the participant or in the medical records
- Myocardial infarction, stroke, transient ischaemic attack or hospitalisation for unstable angina pectoris within 180 days before the day of screening and between screening and initiation visits
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before the day of screening or in the period between screening and initiation visits. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
Other illness
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
Lab values
- Unwilling or unable to avoid concomitant medication e.g., ascorbic acid (vitamin C) that can influence the flash glucose monitoring (FGM) sensor throughout the study and contraindications e.g., implanted medical devices such as pacemakers
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids)
Who the study is looking for
- Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
- Age above or equal to 18 years at the time of signing informed consent
- Diagnosed with type 2 diabetes (T2D) greater than or equal to (\>=) 180 days before screening
- HbA1c from 7.0%-11.0% (53.0-96.7 millimoles per mole \[mmol/mol\]) both inclusive at screening confirmed by central laboratory analysis
- Insulin-naïve. However, short term insulin treatment for a maximum of 14 consecutive days before screening is allowed, as is prior insulin treatment for gestational diabetes
- Stable daily dose(s) \>=90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
- Any metformin formulations \>= 1500 milligrams (mg) or maximum tolerated or effective dose or
- Any metformin combination formulations \>=1500 mg or maximum tolerated or effective dose or
- Other antidiabetic Drugs including combination products (\>=half of the maximum approved dose according to local label or maximum tolerated or effective dose) of the classes specified below: Sulfonylureas, Meglitinides (glinides), Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors, Thiazolidinedione, Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral antidiabetic drugs, Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists
- Intensification with basal insulin is indicated to achieve fasting glycaemic target (4.4-7.2 millimoles per liter \[mmol/L\]; 80-130 milligrams per deciliter \[mg/dL\]) at the discretion of the treating investigator
- Body mass index (BMI) less than or equal to (\<=) 40.0 kilograms per meter square (kg/m\^2)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amarillo Medical Specialists Coordinator of this site? Confirm its status | Amarillo | United States | Unknown status |
| AM Diabetes And Endocrinology Coordinator of this site? Confirm its status | Bartlett | United States | Unknown status |
| Northern Pines Hlth Ctr, PC Coordinator of this site? Confirm its status | Buckley | United States | Unknown status |
| Diabetes & Endocrinology Asso Coordinator of this site? Confirm its status | Canton | United States | Unknown status |
| UT Southwestern Med Cntr Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Velocity Clin Res, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| East West Med Res Inst Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Fmc Science, Llc Coordinator of this site? Confirm its status | Lampasas | United States | Unknown status |
| Palm Research Center Inc-Vegas Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| International Diabetes Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Florida Inst For Clin Res LLC Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Desert Oasis Hlthcr Med Group Coordinator of this site? Confirm its status | Palm Springs | United States | Unknown status |
| Clinical Trials Research_Sacramento_0 Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Northeast Clinical Research of San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Clinical Trials of Texas Inc Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| San Diego Family Care Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Mills-Peninsula Hlth Services Coordinator of this site? Confirm its status | San Mateo | United States | Unknown status |
| Chrysalis Clinical Research Coordinator of this site? Confirm its status | St. George | United States | Unknown status |
| Metabolic Research Institute, Inc Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Accellacare_NC Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.