Clinical Trial Details
| Trial ID: | L2113 |
| Source ID: | NCT04795531 |
| Associated Drug: | Insulin Icodec |
| Title: | A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3) |
| Acronym: | ONWARDS 3 |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT04795531/results |
| Conditions: | Diabetes Mellitus, Type 2 |
| Interventions: | DRUG: Insulin icodec|DRUG: Placebo insulin icodec|DRUG: Insulin degludec|DRUG: Placebo insulin degludec |
| Outcome Measures: | Primary: Change in Glycated Haemoglobin (HbA1c), Change in HbA1c from baseline (week 0) to week 26 is presented. The outcome data is evaluated based on the in-trial observation period. The in-trial 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 | 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. The in-trial 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|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-tratment 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 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose [BG] Meter), Number of clinically significant hypoglycaemic episodes (level 2) (less than \[\<\] 3.0 millimoles per liter (mmol/L) (54 mg/dL), confirmed by 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 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) (less than 3.0 mmol/L) (54 mg/dL), confirmed by blood glucose \[BG\] meter) or severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of \< 3.0 mmol/L (54 mg/dL) confirmed by BG meter. The outcome data was evaluated based on the on-treatment 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|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., From baseline (week 0) to week 26|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 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., From baseline (week 0) to week 26|Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3), Number of clinically significant hypoglycaemic episodes (level 2) (\<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (\<) 3.0 millimoles per liter (mmol/L) (54 milligrams per deciliter \[mg/dL\]) confirmed by blood glucose (BG) meter., From baseline (week 0) 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. The in-trial 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|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 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 |
| Sponsor/Collaborators: | Sponsor: Novo Nordisk A/S |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 588 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT |
| Start Date: | 2021-03-24 |
| Completion Date: | 2022-06-23 |
| Results First Posted: | 2024-12-04 |
| Last Update Posted: | 2024-12-04 |
| Locations: | Lakeview Clinical Research, LLC, Guntersville, Alabama, 35976, United States|American Clinical Trials, Buena Park, California, 90620, United States|Headlands Research California, LLC, Escondido, California, 92025, United States|Valley Research, Fresno, California, 93720, United States|First Valley Medical Group, Lancaster, California, 93534, United States|Est Cst Inst for Rsrch,Jksnvil, Jacksonville, Florida, 32216, United States|Palm Harbor Medical Associates, Palm Harbor, Florida, 34684-3609, United States|Metabolic Research Institute Inc, West Palm Beach, Florida, 33401, United States|Cedar-Crosse Research Center, Chicago, Illinois, 60607, United States|Cotton-Oneill Diabetes and End, Topeka, Kansas, 66606-2806, United States|Arcturus Healthcare, PLC, Troy, Michigan, 48098, United States|Southgate Medical Group, LLP, West Seneca, New York, 14224, United States|Physician's East Endocrinology, Greenville, North Carolina, 27834, United States|Accellacare, Wilmington, North Carolina, 28401, United States|Diab & Endo Assoc of Stark Co, Canton, Ohio, 44718, United States|Providence Health Partners Ctr, Dayton, Ohio, 45439, United States|Prestige Clinical Research, Franklin, Ohio, 45005, United States|Intend Research, Norman, Oklahoma, 73069, United States|Hillcrest Clinical Research, Simpsonville, South Carolina, 29681-1538, United States|Velocity Clinical Res-Dallas, Dallas, Texas, 75230, United States|UT Southwestern Med Cntr, Dallas, Texas, 75390-9302, United States|PrimeCare Medical Group, Houston, Texas, 77024, United States|Texas Diab & Endo, P.A., Round Rock, Texas, 78681, United States|Clinical Trials of Texas, LLC, San Antonio, Texas, 78229, United States|Chrysalis Clinical Research, Saint George, Utah, 84790, United States|Rainier Clin Res Ctr Inc, Renton, Washington, 98057, United States|STAT Research, Buenos Aires, C1023AAB, Argentina|Centro de Investigación Clínica, Caba, C1060ABA, Argentina|Medical Center of Diabetes and Nutrition, Caba, C1440AAD, Argentina|Instituto de Clínica Médica y Diabetes, Mendoza, 5500, Argentina|Universitätsklinik für Innere Medizin Graz, Graz, 8036, Austria|Universitätsklinik für Innere Medizin, Graz, 8036, Austria|Barmh. Brüder Linz, Konventspital, Linz, 4021, Austria|Gesundheitszentrum Hetzendorf, Wien, 1120, Austria|Hanusch-Krankenhaus, Wien, Wien, 1140, Austria|Quanta Diagnóstico Nuclear / Medicina Nuclear Alto da XV, Curitiba, Parana, 80045-170, Brazil|Centro de Diabetes Curitiba, Curitiba, Parana, 80810-040, Brazil|Núcleo de Pesquisa Clínica do Rio Grande do Sul Ltda., Porto Alegre, Rio Grande Do Sul, 90430-001, Brazil|CPQuali Pesquisa Clínica Ltda, São Paulo, Sao Paulo, 01228-000, Brazil|Commonwealth Medical Clinic, Mount Pearl, Newfoundland and Labrador, A1N 1W7, Canada|Eastern Health Authority, St. Johns, Newfoundland and Labrador, A1B 3V6, Canada|LMC Diabetes & Endocrinology (Barrie), Barrie, Ontario, L4N 7L3, Canada|LMC ClinRsrh Inc.Brampton, Brampton, Ontario, L6S 0C6, Canada|LMC (Thornhill), Concord, Ontario, L4K 4M2, Canada|LMC Endo Ctr (Etobicoke) Ltd, Etobicoke, Ontario, M9R 4E1, Canada|Western Univ. Cnt for Studies in Fam Med, London, Ontario, N6G 2M1, Canada|LMC Research Inc. Ottawa, Nepean, Ontario, K2J 0V2, Canada|Bluewater Clin Res Group,Inc, Sarnia, Ontario, N7T 4X3, Canada|Centricity Research LMC, Toronto, Ontario, M4G 3E8, Canada|Dr. Anil K Gupta Medicine Professional Corporation, Toronto, Ontario, M9V 4B4, Canada|ViaCar Recherche Clinique Inc, Brossard, Quebec, J4Z 2K9, Canada|Clinique de Recherche Medpharmgene Inc., Montreal, Quebec, H1Y 3L1, Canada|LMC Clin Rsrch Inc. (Montreal), Saint-Laurent, Quebec, H4T 1Z9, Canada|Diex Recherche Victoriaville, Victoriaville, Quebec, G6P 6P6, Canada|Chinese People's Liberation Army General Hospital, Beijing, Beijing, 100853, China|Beijing Pinggu Hospital, Beijing, Beijing, 101200, China|Chongqing University Three Gorges Hospital, ChongQing, Chongqing, 404000, China|Cangzhou People's Hospital, Cangzhou, Hebei, 061000, China|Harrison International Peace Hospital, Hengshui, Hebei, 053000, China|Changzhou No.2 People's Hospital, Yanghu Branch, Changzhou, Jiangsu, 213003, China|The Second Affiliated Hospital of Nanjing Medical University_Nanjing, Nanjing, Jiangsu, 210011, China|Nanjing Jiangning Hospital, Nanjing, Jiangsu, 211199, China|The Affiliated Hospital of Jiangsu University_Zhenjiang, Zhenjiang, Jiangsu, 212001, China|Jinan Central Hospital, Ji'nan, Shandong, 250013, China|Shanghai Tenth People's Hsopital, Tongji University, Shanghai, Shanghai, 200072, China|Shanghai Fifth People's Hospital, Shanghai, Shanghai, 200240, China|General Hospital of Tianjin Medical University, Tianjin, Tianjin, 300052, China|Edumed Broumov, Broumov, 550 01, Czechia|Diahelp - diabetologie, Pardubice, 530 02, Czechia|DIALINE s.r.o., Plzeň 3, 301 00, Czechia|Diabet2 s.r.o., Praha 1, 110 00, Czechia|EUC Klinika Praha a.s., Praha 5, 150 00, Czechia|Fledip s.r.o., Praha 6, 160 00, Czechia|Aarhus Universitetshospital Diabetes og Hormonsygdomme, Aarhus N, 8200, Denmark|Sydvestjysk Sygehus Esbjerg, Esbjerg, 6700, Denmark|Steno Diabetes Center Cph_Steno Diabetes Center Cph, Hellerup, 2900, Denmark|Hvidovre Hospital Endokrinologisk forsk. afs. 159, Hvidovre, 2650, Denmark|Les Hopitaux de Chartres-Hopital Louis Pasteur, Le Coudray, 28630, France|Centre Hospitalier de Narbonne, Narbonne, 11100, France|Ap-Hp-Hopital Bichat-Claude Bernard-1, Paris, 75877, France|Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-2, Pessac, 33600, France|Hospices Civils de Lyon-Hopital Lyon Sud-1, Pierre Benite, 69310, France|Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-3, Saint Herblain, 44800, France|Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-2, Toulouse, 31054, France|Centre de Recherche Clinique Portes Du Sud, Venissieux, 69200, France|Arechavaleta Granell María del Rosario, Guadalajara, Jalisco, 44650, Mexico|Investigación Médica Sonora S.C., Hermosillo, Sonora, 83280, Mexico|Advanced Clinical Research LLC, Bayamon, 00959, Puerto Rico|Changhua Christian Hospital, Changhua City, 500, Taiwan|Chung Shan Medical University Hospital, Taichung City, 402, Taiwan|Taichung Veterans General Hospital, Taichung, 407, Taiwan|Chi Mei Medical Center, Tainan City, 710, Taiwan|Taipei Veterans General Hospital, Taipei, 112, Taiwan |
| URL: | https://clinicaltrials.gov/show/NCT04795531 |
| Drug ID | Drug Name | Type | DrugBank ID | Targets | Category | Latest Progress |
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