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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1271-9296 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Icodec | Experimental | Participants will receive 70 Units (U) insulin icodec subcutaneously once-weekly for 26 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Icodec | Drug | Participants will receive insulin icodec once-weekly subcutaneously into the thigh, upper arm or abdomen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycosylated Haemoglobin (HbA1c) | Change in HbA1c from week 0 to week 26 is presented in percentage-point. | Baseline (week 0), week 26 |
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Inclusion Criteria:
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:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 92262 | United States | ||
| Clinical Trials Research_Sacramento_0 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40040516 | Derived | Bergenstal RM, Asbjornsdottir B, Johanning Bari T, Hulkund S, Winhofer Y, Wysham C. Continuous Glucose Monitoring-Based Titration of Once-Weekly Insulin Icodec in Insulin-Naive Individuals with Type 2 Diabetes (ONWARDS 9): A Phase 3b, Multicenter, Single-Arm, Treat-to-Target Clinical Trial. Diabetes Technol Ther. 2025 Jul;27(7):527-536. doi: 10.1089/dia.2025.0050. Epub 2025 Mar 5. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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The trial explores the initiation and titration of once-weekly insulin icodec using intermittently scanned continuous glucose monitoring (isCGM) device system in combination with non-insulin antidiabetic drugs in insulin-naïve participants with type 2 diabetes (T2D). The trial included up to 2 weeks of screening period, a 2-week run-in period, a 26-week intervention period and a 5-week follow-up period.
The trial was conducted at 9 sites in United States of America.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Icodec | Participants received insulin icodec subcutaneously (into the thigh, upper arm or abdomen) once-weekly for 26 weeks. The starting dose was 70 Units (U). The treat-to-target approach was applied to optimise glycaemic control throughout the trial. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2022 | Apr 9, 2026 |
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| Sacramento |
| California |
| 95821 |
| United States |
| San Diego Family Care | San Diego | California | 92111 | United States |
| Mills-Peninsula Hlth Services | San Mateo | California | 94401 | United States |
| Florida Inst For Clin Res LLC | Orlando | Florida | 32825 | United States |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | United States |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | United States |
| Northern Pines Hlth Ctr, PC | Buckley | Michigan | 49620 | United States |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89148 | United States |
| Accellacare_NC | Wilmington | North Carolina | 28401 | United States |
| Diabetes & Endocrinology Asso | Canton | Ohio | 44718 | United States |
| AM Diabetes And Endocrinology | Bartlett | Tennessee | 38133 | United States |
| Amarillo Medical Specialists | Amarillo | Texas | 79124 | United States |
| Velocity Clin Res, Dallas | Dallas | Texas | 75230 | United States |
| UT Southwestern Med Cntr | Dallas | Texas | 75390-9302 | United States |
| Fmc Science, Llc | Lampasas | Texas | 76550 | United States |
| Clinical Trials of Texas Inc | San Antonio | Texas | 78229 | United States |
| Northeast Clinical Research of San Antonio | San Antonio | Texas | 78233 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Full Analysis Set |
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| Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all participants assigned to insulin icodec.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Icodec | Participants received insulin icodec subcutaneously (into the thigh, upper arm or abdomen) once-weekly for 26 weeks. The starting dose was 70 Units (U). The treat-to-target approach was applied to optimise glycaemic control throughout the trial. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Glycosylated Haemoglobin (HbA1c) | Change in HbA1c from week 0 to week 26 is presented in percentage-point. | Full analysis set included all participants assigned to study intervention. Here, Overall Number of Participants Analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage-point of HbA1c | Baseline (week 0), week 26 |
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From week 0 up to week 31
All presented adverse events (AEs) are treatment emergent (i.e., TEAEs). All AEs reported occurred from the initiation of insulin icodec until the end of the study. Safety analysis set (SAS) included all participants who are exposed to insulin icodec.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Icodec | Participants received insulin icodec subcutaneously (into the thigh, upper arm or abdomen) once-weekly for 26 weeks. The starting dose was 70 Units (U). The treat-to-target approach was applied to optimise glycaemic control throughout the trial. | 0 | 51 | 2 | 51 | 17 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Snake bite | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
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At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 9, 2023 | Apr 9, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C000712207 | insulin icodec |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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