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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1247-4945 | Other Identifier | World Health Organization (WHO) | |
| 2020-000454-10 | EudraCT Number |
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This study compares insulin icodec (a new insulin taken once a week) to insulin degludec (an insulin taken once daily which is already available on the market) in people with type 2 diabetes.
The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance.
The insulin is 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 17 clinic visits and 13 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit.
Participants will be asked to wear a sensor that measures their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study.
Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin icodec | Experimental | Insulin icodec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period. |
|
| Insulin degludec | Active Comparator | Insulin degludec + non-insulin anti-diabetic drugs. Pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which must be discontinued at randomisation. The background medication should be maintained at the stable, pre-trial dose and at the same frequency during the entire treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin degludec | Drug | Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily for 26 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | Change in HbA1c from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | Baseline (Week 0), Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose (FPG) | Change in FPG from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. |
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Inclusion Criteria:
Male or female aged above or equal to 18 years at the time of signing informed consent.
Diagnosed with T2D greater than or equal to 180 days prior to the day of screening.
HbA1c from 7.0-10.0% (53.0 85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
Treated with once daily or twice daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL): greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to screening:
Body mass index (BMI) below or equal to 40.0 kg/m^2.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Clinical Trials | Buena Park | California | 90620 | United States | ||
| Cedars-Sinai Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36106652 | Result | Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14. | |
| 37148899 |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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After randomisation participants continued their pre-trial non-insulin anti-diabetic background medication throughout the entire trial except from sulfonylureas and glinides, which had to be discontinued at randomisation.
The trial was conducted at 71 sites in 9 countries as follows: United States of America (USA) (26), Ukraine (4), Portugal (6), Poland (3), Republic of Korea (7), Japan (9), Germany (6), Bulgaria (4), South Africa (6).
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Icodec | Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec for 26 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% of their 7 times total daily basal insulin dose. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. |
| 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 | Apr 14, 2021 | Jan 28, 2025 |
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| Insulin Icodec | Drug | Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks |
|
| Baseline (Week 0), Week 26 |
| Percentage of Time in Target-range 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System | The percentage of time in target-range 3.9-10.0 mmol/L (70-180 milligrams per deciliter [mg/dL]) using continuous glucose monitoring (CGM) system is presented. Time in target range is defined as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | From week 22 to week 26 |
| Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction | Change in DTSQs in total treatment satisfaction from baseline (week 0) to week 26 is presented. The DTSQ domain score in total treatment satisfaction was calculated by adding the six item scores of items 1, 4-8. Higher scores indicate higher levels of treatment satisfaction for items 1, 4 -8. For items 2 and 3 a higher score indicates a participant perceived experience of hyperglycaemia and hypoglycaemia. Lower scores indicate a perception of blood glucose levels being unacceptably high (item 2) or low (item 3). The score has a minimum of 0 and a maximum of 36. The outcome data was evaluated based on in-trial observation period. In-trial observation period started at randomisation and ended at the date of: Last direct participant-site contact, withdrawal for participants who withdrew their informed consent, last participant-investigator contact as defined by the investigator for participants who were lost to follow-up and death for participants who died before any of the above. | Baseline (Week 0), Week 26 |
| 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 on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product. | From baseline (week 0) to week 31 |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product. | From baseline (week 0) to week 31 |
| 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 blood glucose (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 in-trial observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. | From baseline (week 0) to week 31 |
| Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of tiime spent < 3.0 millimoles per liter (mmol/L) (54 mg/dL) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | From week 22 to week 26 |
| Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent > 10 millimoles per liter (mmol/L) (180 milligrams per deciliter [mg/dL]) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | From week 22 to week 26 |
| Mean Weekly Insulin Dose | Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product. | From week 24 to week 26 |
| Change in Body Weight | Change in body weight from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | Baseline (Week 0), Week 26 |
| Encino |
| California |
| 91436 |
| United States |
| Valley Research | Fresno | California | 93720 | United States |
| Diabetes/Lipid Mgmt & Res Ctr | Huntington Beach | California | 92648 | United States |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | United States |
| Clinical Trials Research_Sacramento | Lincoln | California | 95648 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 92262 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| South Broward Research LLC | Miramar | Florida | 33027 | United States |
| Renstar Medical Research | Ocala | Florida | 34470 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Endo Res Solutions Inc | Roswell | Georgia | 30076 | United States |
| Velocity Clin. Res Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Four Rivers Clinical Research Inc | Paducah | Kentucky | 42001 | United States |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | United States |
| Ileana J Tandron APMC | Slidell | Louisiana | 70461-4231 | United States |
| Endo And Metab Cons | Rockville | Maryland | 20852 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115-5804 | United States |
| MassResearch, LLC | Waltham | Massachusetts | 02453 | United States |
| Palm Research Center Inc. | Las Vegas | Nevada | 89148 | United States |
| AMC Community Endocrinology | Albany | New York | 12203 | United States |
| Northport VA Med Ctr Northport | Northport | New York | 11768 | United States |
| Mountain Diabetes & Endocrine Center | Asheville | North Carolina | 28803 | United States |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | United States |
| Accellacare | Wilmington | North Carolina | 28401 | United States |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | United States |
| Osvaldo A. Brusco MD PA | Corpus Christi | Texas | 78414 | United States |
| Thyroid, Endocrinology, and Diabetes, PA | Dallas | Texas | 75208 | United States |
| Baylr Sctt White Rs Inst, Endo | Dallas | Texas | 75226 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| UT Southwestern Med Cntr | Dallas | Texas | 75390-9302 | United States |
| Diabetes and Thyroid Ctr of FW | Fort Worth | Texas | 76132 | United States |
| PlanIt Research, PLLC | Houston | Texas | 77079 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| Simcare Medical Research, LLC | Sugar Land | Texas | 77478 | United States |
| Hillcrest Family Health Center | Waco | Texas | 76708 | United States |
| Capital Clin Res Ctr,LLC | Olympia | Washington | 98502 | United States |
| Medical center Medi City 21 OOD | Kyustendil | 2500 | Bulgaria |
| MHAT Med Line Clinic | Plovdiv | 4000 | Bulgaria |
| OCIPSOMCEMD ENDO MED-CONSULT - Dr. Nikolay Botushanov | Plovdiv | 4002 | Bulgaria |
| ASOMCEM - Individual Practice - Dr. Antoanela Slavcheva | Rousse | 7002 | Bulgaria |
| MMA-MHAT Sofia, Clinic of Endocrinology and Metab. Diseases | Sofia | 1606 | Bulgaria |
| UMHAT Sofiamed EAD | Sofia | 1797 | Bulgaria |
| InnoDiab Forschung GmbH | Essen | 45136 | Germany |
| Wendisch/Dahl Hamburg (DZHW) | Hamburg | 22607 | Germany |
| Milek, Hohenmölsen | Hohenmölsen | 06679 | Germany |
| Institut für Diabetesforschung GmbH Münster - Dr. med. Rose | Münster | 48145 | Germany |
| Praxis Dr. med. Wenzl-Bauer | Rehlingen-Siersburg | 66780 | Germany |
| Zentrum für klinische Studien Alexander Segner | Saint Ingbert-Oberwürzbach | 66386 | Germany |
| VvP Kliniken gGmbH Marienhospital Stuttgart - Innere Medizin I | Stuttgart | 70199 | Germany |
| MZM Praxis Drs. Erlinger | Stuttgart | 70378 | Germany |
| Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine | Chigasaki-shi | Kanagawa, Japan | 253-0044 | Japan |
| Heiwadai Hospital_Internal Medicine | Miyazaki | Miyazaki | 880-0034 | Japan |
| Tokuyama clinic_Diabetic internal medicine | Chiba | 261-0004 | Japan |
| Futata Tetsuhiro Clinic Meinohama_Internal medicine | Fukuoka-shi, Fukuoka | 819-0006 | Japan |
| Naka Kinen Clinic_Internal medicine | Ibaraki | 311-0113 | Japan |
| Yuri Ono Clinic | Sapporo-shi, Hokkaido | 060-0001 | Japan |
| Oyama East Clinic_Internal Medicine | Tochigi | 323-0022 | Japan |
| Juntendo University Hospital_Tokyo | Tokyo | 113-8431 | Japan |
| Noritake Clinic | Ushiku-shi, Ibaraki | 300-1207 | Japan |
| Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A. | Lodz | 90-338 | Poland |
| NZOZ "DiabMed" Poradnia Diabetologiczna | Poznan | 60-821 | Poland |
| Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji | Warsaw | 02-507 | Poland |
| Unidade Local De Saude De Matosinhos E.P.E. | Senhora Da Hora, Matosinhos | Matosinhos | 4464-513 | Portugal |
| Unidade Local De Saude De Almada-Seixal E.P.E. - Hospital Garcia de Orta | Almada | 2805-267 | Portugal |
| Unidade Local de Saúde de Coimbra, E.P.E. | Coimbra | 3000-561 | Portugal |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. - Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| Unidade Local de Saúde de Santo António, E.P.E | Porto | 4099-001 | Portugal |
| Unidade Local de Saude de Sao Joao E.P.E | Porto | 4200-319 | Portugal |
| Hospital Luz Arrabida, S.A. | Vila Nova de Gaia | 4400-346 | Portugal |
| Greenacres Hospital | Port Elizabeth | Eastern Cape | 6045 | South Africa |
| Medi-Clinic Bloemfontein | Bloemfontein | Free State | 9301 | South Africa |
| Hemant Makan | Johannesburg | Gauteng | 1827 | South Africa |
| Chris Hani Baragwanath Hospital | Johannesburg | Gauteng | 2013 | South Africa |
| Centre for Diabetes | Johannesburg | Gauteng | 2198 | South Africa |
| Dr A Amod | Durban | KwaZulu-Natal | 4092 | South Africa |
| The Catholic University of Korea, ST. Vincent's Hospital | Suwon | Gyeonggi-do | 16247 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Nowon Eulji Medical Center, Eulji University | Seoul | 139-827 | South Korea |
| "University Clinic" of Dnipro State Medical University - Endocrinology department | Dnipro | 49038 | Ukraine |
| Department of Medical Service and Rehabilitation of "ARTEM" - day hospital department | Kyiv | 04053 | Ukraine |
| Komisarenko Institute of Endocrinology and Metabolism of NAMSU - Department of paediatric endocrine pathology | Kyiv | 04114 | Ukraine |
| Ternopil Central District Hospital - Outpatient department | Ternopil | 46001 | Ukraine |
| Philis-Tsimikas A, Asong M, Franek E, Jia T, Rosenstock J, Stachlewska K, Watada H, Kellerer M. Switching to once-weekly insulin icodec versus once-daily insulin degludec in individuals with basal insulin-treated type 2 diabetes (ONWARDS 2): a phase 3a, randomised, open label, multicentre, treat-to-target trial. Lancet Diabetes Endocrinol. 2023 Jun;11(6):414-425. doi: 10.1016/S2213-8587(23)00093-1. Epub 2023 May 3. |
| 40465144 | Derived | Philis-Tsimikas A, Krogsdahl Bache J, Fu A, Kellerer M, Salvesen-Sykes K, Bain SC. Insights on Hospitalisations from the Phase 3a ONWARDS 1-6 Trials of Once-Weekly Insulin Icodec. Diabetes Ther. 2025 Aug;16(8):1615-1631. doi: 10.1007/s13300-025-01745-4. Epub 2025 Jun 4. |
| 40186685 | Derived | Riddell MC, Heller S, Carstensen L, Rocha TMP, Kehlet Watt S, Woo VC. The effect of once-weekly insulin icodec vs once-daily basal insulin on physical activity-attributed hypoglycaemia in type 2 diabetes: a post hoc analysis of ONWARDS 1-5. Diabetologia. 2025 Jul;68(7):1416-1422. doi: 10.1007/s00125-025-06414-6. Epub 2025 Apr 5. |
| 39368488 | Derived | Polonsky W, Benamar M, Carstensen L, Davies M, Meller Donatsky A, Franek E, Kellerer M, Philis-Tsimikas A, Goldenberg R. Improved treatment satisfaction with once-weekly insulin icodec compared with once-daily basal insulin in individuals with type 2 diabetes: An analysis of patient-reported outcomes and participant interviews from ONWARDS 2 and 5 and a physician survey from ONWARDS 1. Diabetes Res Clin Pract. 2024 Nov;217:111885. doi: 10.1016/j.diabres.2024.111885. Epub 2024 Oct 4. |
| 39344833 | Derived | Watada H, Asbjornsdottir B, Nishida T, Nishimura R, Yamamoto Y, Yamauchi T, Kadowaki T. Efficacy and safety of once-weekly insulin icodec versus once-daily basal insulin in Japanese individuals with type 2 diabetes: A subgroup analysis of the ONWARDS 1, 2 and 4 trials. Diabetes Obes Metab. 2024 Dec;26(12):5882-5895. doi: 10.1111/dom.15960. Epub 2024 Sep 30. |
| FG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
| Exposed |
|
| Full Analysis Set (FAS) |
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| Safety Analysis Set (SAS) |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Full analysis set (FAS) included all randomised participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Icodec | Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec for 26 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% of their 7 times total daily basal insulin dose. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. |
| BG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
| BG002 | Total | Total of all reporting groups |
| 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 |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Glycated Haemoglobin (HbA1c) | Change in HbA1c from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | Full analysis set included all randomised participants. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline (Week 0), Week 26 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) | Change in FPG from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | Baseline (Week 0), Week 26 |
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| Secondary | Percentage of Time in Target-range 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter [mg/dL]) Using Continuous Glucose Monitoring (CGM) System | The percentage of time in target-range 3.9-10.0 mmol/L (70-180 milligrams per deciliter [mg/dL]) using continuous glucose monitoring (CGM) system is presented. Time in target range is defined as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive, divided by the total number of recorded measurements. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage (%) of time | From week 22 to week 26 |
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| Secondary | Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction | Change in DTSQs in total treatment satisfaction from baseline (week 0) to week 26 is presented. The DTSQ domain score in total treatment satisfaction was calculated by adding the six item scores of items 1, 4-8. Higher scores indicate higher levels of treatment satisfaction for items 1, 4 -8. For items 2 and 3 a higher score indicates a participant perceived experience of hyperglycaemia and hypoglycaemia. Lower scores indicate a perception of blood glucose levels being unacceptably high (item 2) or low (item 3). The score has a minimum of 0 and a maximum of 36. The outcome data was evaluated based on in-trial observation period. In-trial observation period started at randomisation and ended at the date of: Last direct participant-site contact, withdrawal for participants who withdrew their informed consent, last participant-investigator contact as defined by the investigator for participants who were lost to follow-up and death for participants who died before any of the above. | Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Least Squares Mean | Standard Error | Score on a scale | Baseline (Week 0), Week 26 |
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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 on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Episodes | From baseline (week 0) to week 31 |
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| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) | Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Episodes | From baseline (week 0) to week 31 |
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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 blood glucose (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 in-trial observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. | Safety analysis set included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Episodes | From baseline (week 0) to week 31 |
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| Secondary | Percentage of Time Spent < 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of tiime spent < 3.0 millimoles per liter (mmol/L) (54 mg/dL) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage (%) of time | From week 22 to week 26 |
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| Secondary | Percentage of Time Spent > 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent > 10 millimoles per liter (mmol/L) (180 milligrams per deciliter [mg/dL]) using continuous glucose monitoring (CGM) system is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage (%) of time | From week 22 to week 26 |
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| Secondary | Mean Weekly Insulin Dose | Estimated mean weekly insulin dose during the last 2 weeks of treatment (from week 24 to week 26) is presented. The outcome data was evaluated based on the on-treatment observation period. The on-treatment period started at the date of first dose of trial product as recorded on the electronic case report form (eCRF), and ended at the first date of any of the following: The end of trial visit (V30), the last date on trial product + 5 weeks for once daily insulin and + 6 weeks for once weekly insulin (corresponding to 5 weeks after the end of the dosing interval for both treatment arms) and the end-date for the in-trial observation period. The on-treatment period represented the time period in which a participant was considered exposed to trial product. | Full analysis set included all randomised participants. | Posted | Least Squares Mean | 95% Confidence Interval | Units of insulin | From week 24 to week 26 |
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| Secondary | Change in Body Weight | Change in body weight from baseline week 0 to week 26 is presented. The outcome data was evaluated based on the in-trial observation period. In-trial observation period started at randomisation and ended at the date of: The last direct participant-site contact, withdrawal for participants who withdrew their informed consent, the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e., possibly an unscheduled phone visit) and death for participants who died before any of the above. | Full analysis set included all randomised participants. | Posted | Least Squares Mean | Standard Error | Kilograms (kg) | Baseline (Week 0), Week 26 |
|
From baseline (Week 0) to Week 31
All presented adverse events (AEs) are treatment emergent. A treatment-emergent AE (TEAE) was defined as an AE that initiated or worsened on or after the date of first dose of study drug up to the end of the trial period (week 31). Results are based on the safety analysis set which included all randomised participants assigned to trial treatment and who took at least 1 dose of trial product.
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 | Insulin Icodec | Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec for 26 weeks, using PDS290 prefilled pen-injector at a starting dose of 7 times the pre-trial total daily basal insulin dose + 50% of their 7 times total daily basal insulin dose. The following weekly dose was 7 times the total daily dose of the respective participants ('unit to unit switch' approach: current daily dose x 7). Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 millimoles per liter (mmol/L): dose reduced by 3 units (U); 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. | 2 | 262 | 22 | 262 | 50 | 262 |
| EG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. | 2 | 263 | 16 | 263 | 39 | 263 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Adrenocortical insufficiency acute | Endocrine disorders | MedDRA 24 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 24 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Colon cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Gastric dysplasia | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Inappropriate antidiuretic hormone secretion | Endocrine disorders | MedDRA 24 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Pancreatic pseudocyst | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Paraspinal abscess | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Thalamic infarction | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Thrombotic stroke | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Toe amputation | Surgical and medical procedures | MedDRA 24 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinopathy | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 24 | 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 | Mar 2, 2021 | Jan 28, 2025 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C571886 | insulin degludec |
| C000712207 | insulin icodec |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|
| OG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|
| OG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|
| OG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|
| OG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|
| OG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|
| OG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|
| OG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|
| OG001 | Insulin Degludec | Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|
| Insulin Degludec |
Participants were to receive once daily s.c. injection of Insulin degludec for 26 weeks, using PDS290 prefilled pen-injector at a dose in accordance with local label. Participants were to perform once daily SMPG. The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: < 4.4 mmol/L: dose reduced by 20 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 20 U. |
|
|