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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1247-5269 | Other Identifier | World Health Organization (WHO) | |
| 2020-000474-16 | EudraCT Number |
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This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (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 glargine 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 glargine that participants will have to inject once a day at the same time every day. Which treatment participants will get is decided by chance. Participants will also get a mealtime insulin.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 + insulin aspart | Experimental | Participants will get once weekly injections in combination with 2-4 times daily injections of insulin aspart |
|
| Insulin glargine + insulin aspart | Active Comparator | Participants will get once daily injections in combination with 2-4 times daily injections of insulin aspart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin icodec | Drug | Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly 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:
Metformin / Sulfonylureas / Meglitinides (glinides) / DPP-4 inhibitors / SGLT2 inhibitors / Thiazolidinediones / Alpha-glucosidase inhibitors / Oral combination products (for the allowed individual oral anti-diabetic drugs) / Oral or injectable GLP-1-receptor agonists
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 |
|---|---|---|---|---|---|---|
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72204 | United States | ||
| Anaheim Clinical Trials |
| 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. | |
| 37156252 |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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The trial duration is approximately 33 weeks, consisting of a 2-week screening period, followed by a 26-week randomised treatment period and a 5-week follow-up period.
The trial was conducted at 83 sites in 9 countries as follows: Belgium (5), India (9), Italy (6), Japan (9), Mexico (3), Netherlands (5), Romania (6), Russia (10), United States (30).
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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 in combination with insulin aspart 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: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
| 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 | Jun 15, 2025 |
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| Insulin glargine | Drug | Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 26 weeks |
|
| Insulin aspart | Drug | Participants will receive subcutaneous (s.c.) injections of insulin aspart 2-4 times daily for 26 weeks |
|
| Baseline (week 0), Week 26 |
| Percentage of Time in Target-range 3.9-10.0 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | 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 from week 22 to week 26 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 |
| Number of Severe Hypoglycaemic Episodes (Level 3) | Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the on-treatment observation period. The on-treatment observation 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, 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 |
| Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL) Confirmed by Blood Glucose (BG) Meter) | Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). The outcome data was evaluated based on the on-treatment observation period. The on-treatment observation 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, 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 |
| 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) | Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the in-trial observation period. The on-treatment observation 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, 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 Below 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent less than (<) 3.0 mmol/L (54 mg/dL) using CGM system from week 22 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. | From week 22 to week 26 |
| Percentage of Time Spent Above 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent > 10 mmol/L (180 mg/dL) using CGM system from week 22 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. | 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 observation 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, 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 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 |
| Anaheim |
| California |
| 92801 |
| United States |
| John Muir Physicians Network | Concord | California | 94520 | United States |
| Valley Research | Fresno | California | 93720 | United States |
| Diabetes/Lipid Mgmt & Res Ctr | Huntington Beach | California | 92648 | United States |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | United States |
| Clinical Trials Research_Sacramento_0 | Sacramento | California | 95821 | United States |
| Diabetes Research Center | Tustin | California | 92780 | United States |
| Coastal Metabolic Research Center | Ventura | California | 93003 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | United States |
| MedStar Diabetes Institute | Washington D.C. | District of Columbia | 20010 | United States |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | United States |
| Clinical Trial Res Assoc,Inc | Plantation | Florida | 33324 | United States |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Physicians Research Assoc. LLC | Lawrenceville | Georgia | 30046 | United States |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | United States |
| Saltzer Medical Group Research | Nampa | Idaho | 83686-6011 | United States |
| Velocity Clin. Res Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| MassResearch, LLC | Waltham | Massachusetts | 02453 | United States |
| Jefferson City Medical Group, PC | Jefferson City | Missouri | 65109 | United States |
| VA NEB - Western IA Health Stm | Omaha | Nebraska | 68105 | United States |
| Methodist Physicians Clin | Omaha | Nebraska | 68114 | United States |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89148 | United States |
| AMC Community Endocrinology | Albany | New York | 12206 | United States |
| Northport VA Medical Center_Northport_0 | Northport | New York | 11768 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | United States |
| Mountain Diabetes & Endocrine Center | Asheville | North Carolina | 28803 | United States |
| Physician's East Endocrinology | Greenville | North Carolina | 27834 | United States |
| Your Diabetes Endocrine Nutrition Group, Inc. | Mentor | Ohio | 44060 | United States |
| Oregon Health & Science University_Portland_0 | Portland | Oregon | 97239 | United States |
| Indiana-Armstrong Endocrinology Associates | Indiana | Pennsylvania | 15701 | United States |
| Prisma Health-Upstate | Greenville | South Carolina | 29605-4254 | United States |
| AM Diabetes And Endocrinology Center | Bartlett | Tennessee | 38133 | United States |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| Holston Medical Group | Kingsport | Tennessee | 37660 | United States |
| Vanderbilt Diab Obes Clin Tri | Nashville | Tennessee | 37212 | United States |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | United States |
| Texas Diab & Endo, P.A. | Austin | Texas | 78731 | United States |
| Texas Diabetes & Endocrinology | Austin | Texas | 78749 | United States |
| Osvaldo A. Brusco MD PA | Corpus Christi | Texas | 78414 | United States |
| Baylr Sctt White Rs Inst, Endo | Dallas | Texas | 75226 | United States |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | United States |
| North Texas Endocrine Center | Dallas | Texas | 75231 | United States |
| UT Southwestern Med Cntr | Dallas | Texas | 75390-9302 | United States |
| Protenium Clinical Research_Hurst | Fort Worth | Texas | 76113 | United States |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | United States |
| Capital Clin Res Ctr,LLC | Olympia | Washington | 98502 | United States |
| Imeldaziekenhuis - Bonheiden - Department of Endocrinology | Bonheiden | 2820 | Belgium |
| CHU Helora - Site Warquignies | Boussu | 7300 | Belgium |
| Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie | Brussels | 1200 | Belgium |
| UZA - UZ Antwerpen - Department of Endocrinology | Edegem | 2650 | Belgium |
| UZ Leuven - Endocrinology | Leuven | 3000 | Belgium |
| Kurnool Medical Collage | Kurnool | Andhra Pradesh | 518002 | India |
| Medanta - The Medicity Multi-Speciality Hospital, Gurugram | Gurgaon | Haryana | 122001 | India |
| St.John's Hospital | Bangalore | Karnataka | 560034 | India |
| Bangalore Clinisearch | Bangalore | Karnataka | 560043 | India |
| Lifecare Hospital and Research Centre | Bangalore | Karnataka | 560092 | India |
| Belgaum Diabetes Centre | Belagavi | Karnataka | 590001 | India |
| Manipal Hospital, Hebbal, Bengaluru | Bengaluru | Karnataka | 560 024 | India |
| Renai Medicity | Kochi | Kerala | 682025 | India |
| Prince Aly Khan Hospital | Mumbai | Maharashtra | 400010 | India |
| BSES MG hospital | Mumbai | Maharashtra | 400058 | India |
| Grant Medical Foundation | Pune | Maharashtra | 411001 | India |
| Max Super Speciality Hospital, Saket | New Delhi | National Capital Territory of Delhi | 110017 | India |
| Fortis Hospital, Shalimar Bagh, New Delhi | New Delhi | National Capital Territory of Delhi | 110088 | India |
| Maulana Azad Medical College | Delhi | New Delhi | 110002 | India |
| All India Institute of Medical Sciences | New Dehli | New Delhi | 110029 | India |
| S.C.B. Medical College | Cuttack | Odisha | 753007 | India |
| Diabetes, Thyroid and Endocrine Centre | Jaipur | Rajasthan | 302006 | India |
| A.O.U. Università Studi della Campania "Luigi Vanvitelli" | Naples | Campania | 80138 | Italy |
| Azienda Ospedaliero-Universitaria Renato Dulbecco | Catanzaro | Cz | 88100 | Italy |
| Istituto Scientifico San Raffaele | Milan | MI | 20132 | Italy |
| A.O.Universitaria S.ORSOLA-MALPIGHI - U.O.Endocrinologia e Cura | Bologna | 40138 | Italy |
| Università degli Studi G. D'Annunzio | Chieti | 66100 | Italy |
| Universita Degli Studi Di Roma La Sapienza - Policlinico Umberto I Medicina Sperimentale | Roma | 00161 | Italy |
| Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine | Chigasaki-shi | Kanagawa, Japan | 253-0044 | Japan |
| Futata Tetsuhiro Clinic Meinohama_Internal medicine | Fukuoka-shi, Fukuoka | 819-0006 | Japan |
| Sasaki Internal Medicine | Hokkaido | 062-0007 | Japan |
| Naka Kinen Clinic_Internal medicine | Ibaraki | 311-0113 | Japan |
| Sugimoto Clinic,Internal Medicine | Kitakyusyu-shi, Fukuoka | 800-0222 | Japan |
| Shimizu Clinic Fusa | Saitama | 336-0967 | Japan |
| Oyama East Clinic_Internal Medicine | Tochigi | 323-0022 | Japan |
| The Jikei University Hospital Dept of Diabetes, Metabolic | Tokyo | 105-8471 | Japan |
| Noritake Clinic | Ushiku-shi, Ibaraki | 300-1207 | Japan |
| Centro de Investigacion Medica de Occidente S.C. | Zapopan | Jalisco | 45116 | Mexico |
| Hospital Universitario Dr. José Eleuterio González_Monterrey | Monterrey | Nuevo León | 64460 | Mexico |
| Unidad Biomedica Avanzada Monterrey | Monterrey | Nuevo León | 64460 | Mexico |
| Gelre Ziekenhuizen Apeldoorn | Apeldoorn | 7334 DZ | Netherlands |
| Rijnstate Ziekenhuis | Arnhem | 6815 AD | Netherlands |
| Maxima Medisch Centrum | Eindhoven | 5631 BM | Netherlands |
| Bethesda Diabetes Research Center en Bethesda ziekenhuis | Hoogeveen | 7909 AA | Netherlands |
| Maastricht Universitair Medisch Centrum | Maastricht | 6229 HX | Netherlands |
| Ikazia Ziekenhuis | Rotterdam | 3083 AN | Netherlands |
| Universitair Medisch Centrum Utrecht | Utrecht | 3584 CX | Netherlands |
| Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila | Bucharest | Bucurestii | 020475 | Romania |
| Spitalul Judetean de Urgenta Targoviste | Targoviste | Dâmbovița County | 130083 | Romania |
| Sc Mediab Srl | Târgu Mureş | Mureș County | 540142 | Romania |
| Mariodiab Clinic SRL | Brasov | 500101 | Romania |
| S.C. Medcon S.R.L | Buzău | 120203 | Romania |
| Clinical Emergency Sf. Apostol Andrei Hospital | Galati | 800578 | Romania |
| Tumen State Medical University | Tyumen | Russia | 625023 | Russia |
| Arkhangelsk Regional Clinical Hospital | Arkhangelsk | 163045 | Russia |
| City Hospital #5 | Barnaul | 656045 | Russia |
| KSFMU, Inrereginal Clinical Diagnostic center | Kazan' | 420010 | Russia |
| Kirov Clinical Hospital #7 | Kirov | 610014 | Russia |
| Limited Liability Company "AriVa-Med" | Kursk | 305016 | Russia |
| City Clinical Hospital №52 | Moscow | 123182 | Russia |
| LLC "Centr Targetnoy Terapii" | Moscow | 125008 | Russia |
| Limited Law Company "Healthy Family" Medicine Center" | Novosibirsk | 630099 | Russia |
| SPb SBHI City Outpatient clinic #37 | Saint Petersburg | 191119 | Russia |
| Regional clinical cardiology dispensary | Saratov | 410039 | Russia |
| Mathieu C, Asbjornsdottir B, Bajaj HS, Lane W, Matos ALSA, Murthy S, Stachlewska K, Rosenstock J. Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial. Lancet. 2023 Jun 10;401(10392):1929-1940. doi: 10.1016/S0140-6736(23)00520-2. Epub 2023 May 5. |
| 41051694 | Derived | Mohan V, Kesavadev J, Murthy LS, Anil G, Chandrappa M, Kar S, Mishra S. Efficacy and Safety of Once-Weekly Insulin Icodec in Indian Participants with Diabetes: Results from ONWARDS 1, 4, and 6 Studies. Diabetes Ther. 2025 Nov;16(11):2193-2212. doi: 10.1007/s13300-025-01799-4. Epub 2025 Oct 6. |
| 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. |
| 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 Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
| Full Analysis Set (FAS) |
|
| Safety Analysis Set (SAS) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full analysis set (FAS) included all randomised participants from baseline (week 0) to week 26.
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 in combination with insulin aspart 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: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
| BG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
| 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 |
| ||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 mmol/L (70-180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | 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 from week 22 to week 26 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 | Number of Severe Hypoglycaemic Episodes (Level 3) | Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the on-treatment observation period. The on-treatment observation 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, 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 | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL) Confirmed by Blood Glucose (BG) Meter) | Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). The outcome data was evaluated based on the on-treatment observation period. The on-treatment observation 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, 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 | 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) | Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. The outcome data was evaluated based on the in-trial observation period. The on-treatment observation 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, 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 Below 3.0 mmol/L (54 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent less than (<) 3.0 mmol/L (54 mg/dL) using CGM system from week 22 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 | Mean | Standard Deviation | Percentage (%) of time | From week 22 to week 26 |
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| Secondary | Percentage of Time Spent Above 10 mmol/L (180 mg/dL) Using Continuous Glucose Monitoring (CGM) System | Percentage of time spent > 10 mmol/L (180 mg/dL) using CGM system from week 22 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 | 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 observation 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, 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. | Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure. | 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 AEs are treatment emergent. Treatment emergent adverse events (TEAEs): events that had onset date during on-treatment period, time period in which participants was considered exposed to trial product. Safety analysis set included all randomised participants randomly assigned to trial treatment 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 in combination with insulin aspart 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: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. | 2 | 291 | 22 | 291 | 48 | 291 |
| EG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. | 1 | 291 | 25 | 291 | 44 | 291 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute kidney injury | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Diabetic retinal oedema | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
| |
| Hypoglycaemic coma | Nervous system disorders | MedDRA 24 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 24 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 24 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 24 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Pancreatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 24 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 24 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 24 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Small intestine neuroendocrine tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 24 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 24 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24 | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA 24 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 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 | Jun 15, 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 |
|---|---|
| C000712207 | insulin icodec |
| D000069036 | Insulin Glargine |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
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 Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
|
|
| OG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
|
|
| OG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
|
|
| OG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
|
|
| OG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
|
|
| OG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
|
|
| OG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
|
|
| OG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
|
|
| OG001 | Insulin Glargine | Participants were to receive once daily s.c. injection of Insulin glargine for 26 weeks, using SoloSTAR pre-filled pen-injector in combination with insulin aspart. Participants were to perform 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 3 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 3 U. Dose titration of insulin aspart was based on the respective premeal(s) and bedtime SMPG measured. |
|
|