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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002847-24 | EudraCT Number | ||
| U1111-1281-4752 | Other Identifier | World Health Organization (WHO) |
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This study looks at how a new medicine insulin icodec helps in reducing blood sugar levels when given along with semaglutide in patients with type 2 diabetes. Participants will get the medicine insulin icodec once a week in the first part of the study (run-in period-26 weeks). Participants will only enter the second part of the study if the blood sugar levels have not reduced to normal. If blood sugar levels are normal after the first 26 weeks, participants will continue in a 5-week follow up period. In the second part of the study (intensification period-26 weeks), participants will get both insulin icodec and semaglutide once weekly after which they will continue in a 5-week follow up period. Participants will have to inject the study medicines once a week on the same day of the week in a skin fold in the thigh, upper arm or stomach. The study will last for about 13 months. Participants will get a blood glucose meter to check blood sugar levels. In addition, participants will be asked to enter blood sugar levels in the study phone. In addition, Participants will be asked to enter selected few blood sugar values (three times during the study) in a paper diary that will be provided to participants. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Icodec + Semaglutide | Experimental | Participants will receive insulin icodec once weekly for 26 weeks in run-in period to ensure the dose optimization. Thereafter, participants meeting intensification criteria will proceed to the 26-week treatment period to receive once weekly semaglutide subcutaneously starting from 0.25 milligrams (mg) and dose increased up to 1 mg along with 700 units per milliliter (U/mL) insulin icodec therapy. There are no maximum or minimum insulin doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Icodec | Drug | Participants will receive subcutaneously insulin icodec once weekly for 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | Change in HbA1c (percentage) from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. | Baseline (Week 26), Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles | Change in mean 7-point SMPG profiles from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Edumed Broumov | Broumov | 550 01 | Czechia | |||
| DIAMIN |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42387310 | Derived | Strojek K, Liebl A, Mumbaikar NN, Sogaard SB, Kehlet Watt S, Philis-Tsimikas A. Efficacy and Safety of Intensifying Once-Weekly Insulin Icodec Treatment With Once-Weekly Semaglutide in Adults With Type 2 Diabetes: A Single-Arm, Open-Label, Treat-to-Target, Phase 3b Trial (ONWARDS 8). Diabetes Obes Metab. 2026 Jul 1. doi: 10.1111/dom.71049. Online ahead of print. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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The trial included a 26-week run-in period during which all participants were switched from their previous basal insulin regimen to insulin icodec. This was followed by a 26-week treatment phase with insulin icodec combined with semaglutide.
The trial was conducted in 5 countries as follows: Poland, Serbia, Czechia, Malaysia and Thailand.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Icodec + Semaglutide | Participants received once-weekly insulin icodec during a 26-week run-in period to allow dose optimization. Participants who met the intensification criteria then entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 milligrams (mg) and titrated up to 1.0 mg, concomitant with insulin icodec at 700 units per milliliter (U/mL). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Run-in Period (Week 0 to Week 26) |
|
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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 | Aug 28, 2024 | Apr 14, 2026 |
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| Semaglutide | Drug | Participants will receive once weekly semaglutide subcutaneously starting from 0.25 mg and dose increased up to 1 mg for 26 weeks. |
|
| Baseline (Week 26), Week 52 |
| Change in Mean Post-prandial Glucose Increment (Over All Meals) | Change in mean post-prandial glucose increment from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. | Baseline (Week 26), Week 52 |
| Change in Fasting Plasma Glucose (FPG) | Change in FPG from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. | Baseline (Week 26), Week 52 |
| Number of Severe Hypoglycaemic Episodes (Level 3) | Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). | From baseline (week 26) to week 57 |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 Milligrams Per Deciliter {mg/dL}], Confirmed by Blood Glucose [BG] Meter) | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). | From baseline (week 26) to week 57 |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L [54 mg/dL]), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). | From baseline (week 26) to week 57 |
| Change in Body Weight | Change in body weight from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). | Baseline (Week 26), Week 52 |
| Relative Change in Weekly Insulin Icodec Dose | Relative change in weekly insulin icodec dose from week 25 to week 52 is presented. | From week 25 to week 52 |
| Chrudim |
| 537 01 |
| Czechia |
| Diabetologické centrum s.r.o. | Olomouc | 779 00 | Czechia |
| DIALINE s.r.o. | Plzeň 3 | 301 00 | Czechia |
| Diabet2 s.r.o. | Prague | 110 00 | Czechia |
| Medicon a.s. | Prague | 140 00 | Czechia |
| Diabetologická a endokrinologická ambulance Praha | Prague | 140 21 | Czechia |
| EUC Klinika Praha a.s. | Prague | 150 00 | Czechia |
| Comfort Care Praha s.r.o. | Praha 4 - Chodov | 148 00 | Czechia |
| DiaPodi care s.r.o. | Soběslav I | 39201 | Czechia |
| Hospital Canselor Tuanku Muhriz UKM | Cheras | Kuala Lumpur | 56000 | Malaysia |
| Hospital Seri Manjung | Seri Manjung | Perak | 32040 | Malaysia |
| Hospital Putrajaya | Putrajaya | Putrajaya | 62250 | Malaysia |
| Hospital Miri | Miri | Sarawak | 98000 | Malaysia |
| Universiti Teknologi MARA, Sungai Buloh Campus | Sungai Buloh | Selangor | 47000 | Malaysia |
| Med. Cent. Diabet. Endo. Metabol. DIAB-ENDO-MET | Krakow | Lesser Poland Voivodeship | 31-261 | Poland |
| Metabolica Sp. z o.o. | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| Osrodek Badan Klinicznych "METABOLICA" lek. Robert Witek | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski | Gorzów Wielkopolski | Lubusz Voivodeship | 66-400 | Poland |
| NBR Polska | Warsaw | Masovian Voivodeship | 00-710 | Poland |
| Osteo-Medic s.c. A. Racewicz, J. Supronik | Bialystok | 15-351 | Poland |
| Centrum Badan Klinicznych PI-House Sp. z o.o. | Gdansk | 80-546 | Poland |
| NZOZ Gdanska Poradnia Cukrzycowa Sp.z o.o. | Gdansk | 80-858 | Poland |
| NZOZ Gdanska Poradnia Cukrzycowa | Gdansk | 80-858 | Poland |
| Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski | Gorzów Wielkopolski | 66-400 | Poland |
| Centrum Medyczne Pratia Katowice | Katowice | 40-081 | Poland |
| Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia | Lodz | 90-302 | Poland |
| NBR Polska Tomasz Klodawski | Warsaw | 00-710 | Poland |
| Poradnia Chorob Metabolicznych w Wierzchoslawicach | Wierzchosławice | 33-122 | Poland |
| Wojewodzka Poradnia dla Chorych na Cukrzyce w Zabrzu | Zabrze | 41-800 | Poland |
| Santa Sp. z o.o, Santa Familia Centrum Badan, Profilaktyki i Leczenia | Lodz | Łódź Voivodeship | 90-302 | Poland |
| Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis. | Novi Sad | Vojvodina | 21000 | Serbia |
| CHC Zvezdara, Clinical department for endocrinology | Belgrade | 11000 | Serbia |
| Clinical Hospital Centre Zemun | Belgrade | 11080 | Serbia |
| Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department | Kragujevac | 34000 | Serbia |
| King Chulalongkorn Memorial Hospital | Bangkok | 10330 | Thailand |
| Rajavithi Hospital_Diabetes and Endocrinology | Bangkok | 10400 | Thailand |
| Rajavithi Hospital | Bangkok | 10400 | Thailand |
| Ramathibodi Hospital - Ped-Endo and Metabolism | Bangkok | 10400 | Thailand |
| Exposed |
|
| Safety Analysis Set (SAS) |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
| Treatment Period (Week 26 to Week 52) |
|
|
Safety analysis set (SAS) included all participants who were exposed to investigational intervention (s).
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Icodec + Semaglutide | Participants received once-weekly insulin icodec during a 26-week run-in period to allow dose optimization. Participants who met the intensification criteria then entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
|
| 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 Glycated Haemoglobin (HbA1c) | Change in HbA1c (percentage) from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. | Full analysis set (FAS) included all participants allocated to the intensification phase. Overall number of participants analyzed = participants with available data. | Posted | Mean | Standard Deviation | Percentage (%) of HbA1c | Baseline (Week 26), Week 52 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles | Change in mean 7-point SMPG profiles from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. | FAS included all participants allocated to the intensification phase. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | millimoles per liter (mmol/L) | Baseline (Week 26), Week 52 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Mean Post-prandial Glucose Increment (Over All Meals) | Change in mean post-prandial glucose increment from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. | FAS included all participants allocated to the intensification phase. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | Baseline (Week 26), Week 52 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Fasting Plasma Glucose (FPG) | Change in FPG from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the on-intensification phase. On-intensification phase was observed data at planned visits from time of the intensification week 26 until the end of treatment week 52, i.e., for participants who permanently discontinued either insulin icodec or semaglutide treatment, post-discontinuation observations were not included. | FAS included all participants allocated to the intensification phase. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | mmol/L | Baseline (Week 26), Week 52 |
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| Secondary | Number of Severe Hypoglycaemic Episodes (Level 3) | Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). | SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | Episodes | From baseline (week 26) to week 57 |
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| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Less Than [<] 3.0 mmol/L [54 Milligrams Per Deciliter {mg/dL}], Confirmed by Blood Glucose [BG] Meter) | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). | SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | Episodes | From baseline (week 26) to week 57 |
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| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L [54 mg/dL]), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of < 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). | SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Number | Episodes | From baseline (week 26) to week 57 |
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| Secondary | Change in Body Weight | Change in body weight from baseline (week 26) to week 52 is presented. The outcome data was evaluated based on the Treatment-phase-on-treatment period. The Treatment-phase-on-treatment period was all observed data from time of the intensification week 26 until 6 weeks after last date of either insulin icodec or semaglutide treatment (whichever comes last). | SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Kilograms (Kg) | Baseline (Week 26), Week 52 |
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| Secondary | Relative Change in Weekly Insulin Icodec Dose | Relative change in weekly insulin icodec dose from week 25 to week 52 is presented. | SAS included all participants who were exposed to investigational intervention (s). Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Least Squares Mean | 95% Confidence Interval | Insulin Units per Week | From week 25 to week 52 |
|
|
Week 0 to week 57
An adverse event (AE) is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal products (IMP), whether or not considered related to the IMP. AEs are evaluated using SAS included all participants who were exposed to investigational intervention (s).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Icodec: Run-in Period | Participants received once-weekly insulin icodec during a 26-week run-in period to allow dose optimization. | 1 | 148 | 7 | 148 | 14 | 148 |
| EG001 | Insulin Icodec + Semaglutide: Treatment Period | Participants who met the intensification criteria then entered a 26-week treatment period and received once-weekly subcutaneous semaglutide, initiated at 0.25 mg and titrated up to 1.0 mg, concomitant with insulin icodec at 700 U/mL. | 0 | 94 | 3 | 94 | 50 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydrocele | Congenital, familial and genetic disorders | MedDRA 28 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 28 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 28 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 28 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 28 | Systematic Assessment |
| |
| Angina Pectoris | Cardiac disorders | MedDRA 28 | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| Anticoagulation Drug Level Increased | Investigations | MedDRA 28 | Systematic Assessment |
| |
| Metastases To Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28 | Systematic Assessment |
| |
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28 | Systematic Assessment |
| |
| Basal Ganglia Haemorrhage | Nervous system disorders | MedDRA 28 | Systematic Assessment |
| |
| Lacunar Infarction | Nervous system disorders | MedDRA 28 | Systematic Assessment |
| |
| Alcohol Abuse | Psychiatric disorders | MedDRA 28 | Systematic Assessment |
| |
| Hypertensive Urgency | Vascular disorders | MedDRA 28 | Systematic Assessment |
| |
| Peripheral Artery Stenosis | Vascular disorders | MedDRA 28 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 28 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 28 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 28 | Systematic Assessment |
| |
| Diabetic Retinopathy | Eye disorders | MedDRA 28 | Systematic Assessment |
|
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 | Sep 12, 2023 | Apr 14, 2026 | SAP_001.pdf |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000712207 | insulin icodec |
| C000591245 | semaglutide |
Not provided
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Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Counts |
|---|
| Participants |
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