Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate insulin degludec for managing type 1 diabetes mellitus, type 2 diabetes mellitus, and associated conditions such as nocturnal hypoglycemia, assessing glycemic efficacy and safety relative to other insulin regimens. Sponsored by major pharmaceutical corporations and academic institutions, these investigations encompass various recruitment statuses, including completed, currently recruiting, active but not recruiting, enrolling by invitation, and terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07173712 NOT_YET_RECRUITING
Type 2 Diabetes
Yanbing Li
2026-03-15 PHASE4
NCT07032688 RECRUITING
Type 2 Diabetes
Jiangsu HengRui Medicine Co., Ltd.
2025-08-11 PHASE1
NCT07387003 NOT_YET_RECRUITING
Type 2 Diabetes (T2DM)
Gan & Lee Pharmaceuticals.
2026-04-10 PHASE2
NCT07630233 NOT_YET_RECRUITING
Type 2 Diabetes Mellitus (T2DM)
The United Bio-Technology (Hengqin) Co., Ltd.
2026-06-19 PHASE1
NCT06280703 RECRUITING
Healthy; Type 1 Diabetes Mellitus
Eli Lilly and Company
2024-05-15 PHASE1
NCT07527078 RECRUITING
Type 2 Diabetes (T2DM)
Gan & Lee Pharmaceuticals.
2026-04-07 PHASE3
NCT07146347 RECRUITING
Type 2 Diabetes
Gan and Lee Pharmaceuticals, USA
2025-08-15 PHASE1
NCT06685185 COMPLETED
Diabetes Mellitus, Type 1
Novo Nordisk A/S
2024-11-12 PHASE1
NCT07242664 RECRUITING
Type 1 Diabetes Mellitis
Gan and Lee Pharmaceuticals, USA
2025-10-13 PHASE1
NCT06767748 ACTIVE_NOT_RECRUITING
Diabetes
Gan & Lee Pharmaceuticals.
2025-02-15 PHASE3
NCT07018453 ACTIVE_NOT_RECRUITING
Type 2 Diabetes Mellitus
Jiangsu HengRui Medicine Co., Ltd.
2025-07-16 PHASE2
NCT04955834 UNKNOWN
Type 2 Diabetes
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
2021-07-27 PHASE3
NCT05641337 UNKNOWN
Liver Cirrhosis; Diabetes
Huashan Hospital
2022-10-01 PHASE3
NCT06238778 COMPLETED
Diabetes Mellitus, Type 1
Diasome Pharmaceuticals
2023-12-28 PHASE2
NCT06559722 UNKNOWN
Type 2 Diabetes
Tonghua Dongbao Pharmaceutical Co.,Ltd
2024-08 PHASE3
NCT05417841 COMPLETED
Type 2 Diabetes Mellitus
Beijing Hospital
2023-03-23
NCT07599891 COMPLETED
Glucocorticoid Induced Hyperglycemia
Max Healthcare Insititute Limited
2023-09-01 PHASE4
NCT06288412 COMPLETED
Diabetes Mellitus, Type 2
Novo Nordisk A/S
2024-02-26 PHASE1
NCT05218915 COMPLETED
Diabetes Mellitus; Diabetic Kidney Disease
Elaine Chow
2022-01-28 PHASE4
NCT05802862 COMPLETED
Diabetes
Sunshine Lake Pharma Co., Ltd.
2023-07-06 PHASE3
NCT06202079 COMPLETED
Diabetes Mellitus, Type 2
Gan and Lee Pharmaceuticals, USA
2023-08-11 PHASE2
NCT06199505 COMPLETED
Type 2 Diabetes
Gan and Lee Pharmaceuticals, USA
2023-11-21 PHASE2
NCT06132126 COMPLETED
Healthy; Type 2 Diabetes Mellitus
Eli Lilly and Company
2023-11-17 PHASE1
NCT06449703 UNKNOWN
Healthy
Tonghua Dongbao Pharmaceutical Co.,Ltd
2024-05-06 PHASE1
NCT06178874 COMPLETED
Glycemic Control; Insulin; Critical Illness
Ain Shams University
2023-12-01
NCT05275400 COMPLETED
Type 2 Diabetes
Eli Lilly and Company
2022-03-08 PHASE3
NCT05463744 COMPLETED
Type 1 Diabetes; Diabetes
Eli Lilly and Company
2022-08-12 PHASE3
NCT05362058 COMPLETED
Diabetes; Type 2 Diabetes
Eli Lilly and Company
2022-06-03 PHASE3
NCT05904743 COMPLETED
Diabetes Mellitus, Type 1
Mannkind Corporation
2023-07-07 PHASE4
NCT04965051 UNKNOWN
Type 1 Diabetes Mellitus With Diabetic Gastroparesis; HbA1c; Time in Range
Second Affiliated Hospital, Zhejiang University, School of Medicine
2021-08
NCT06553248 COMPLETED
Diabetes
Gan and Lee Pharmaceuticals, USA
2023-03-22 PHASE1
NCT06199505 Enrolling by invitation
Type 2 Diabetes
Gan and Lee Pharmaceuticals USA
2023-11-27 Phase 2
NCT05767255 UNKNOWN
Diabetes Mellitus, Type 2 Treated With Insulin
Hospital Universitario San Ignacio
2022-12-01 PHASE3
NCT06202079 Recruiting
Diabetes Mellitus Type 2
Gan and Lee Pharmaceuticals USA
2023-08-29 Phase 2
NCT05552859 TERMINATED
Type 2 Diabetes Mellitus; Renal Impairment
Sanofi
2022-12-05 PHASE4
NCT04538352 COMPLETED
Type 2 Diabetes
The Cleveland Clinic
2021-01-18 PHASE4
NCT06556641 COMPLETED
Healthy Subjects
Gan and Lee Pharmaceuticals, USA
2022-12-17 PHASE1
NCT04671043 COMPLETED
Caffeine and Carbohydrate; Carbohydrate Only; Placebo
Insel Gruppe AG, University Hospital Bern
2022-02-04
NCT05243628 COMPLETED
Type 1 Diabetes
Mannkind Corporation
2022-03-31 PHASE4
NCT04623086 COMPLETED
Type 1 Diabetes
University of Washington
2020-02-14 PHASE4
NCT04760626 COMPLETED
Diabetes Mellitus, Type 2
Novo Nordisk A/S
2021-03-01 PHASE3
NCT03737240 COMPLETED
Diabetes Mellitus
Emory University
2019-01-15 PHASE3
NCT04588259 COMPLETED
Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2020-10-09 PHASE3
NCT04795531 COMPLETED
Diabetes Mellitus, Type 2
Novo Nordisk A/S
2021-03-24 PHASE3
NCT03862716 COMPLETED
Type 2 Diabetes Mellitus
Population Health Research Institute
2019-04-23 PHASE3
NCT04663282 COMPLETED
Type 2 Diabetes
Jiangsu HengRui Medicine Co., Ltd.
2021-02-04 PHASE2
NCT04848480 COMPLETED
Diabetes Mellitus, Type 1
Novo Nordisk A/S
2021-04-30 PHASE3
NCT05576298 COMPLETED
Type 2 Diabetes
Sunshine Lake Pharma Co., Ltd.
2021-10-08 PHASE1
NCT05036876 COMPLETED
Type 2 Diabetes
Medanta, The Medicity, India
2021-10-10
NCT04770532 COMPLETED
Diabetes Mellitus, Type 2
Novo Nordisk A/S
2021-03-05 PHASE3
NCT03952130 COMPLETED
Type 1 Diabetes Mellitus
Eli Lilly and Company
2019-05-29 PHASE3
NCT05360537 COMPLETED
Diabetes Mellitus, Type 2
University of Palermo
2021-04-01 PHASE4
NCT04450394 COMPLETED
Type 2 Diabetes Mellitus
Eli Lilly and Company
2020-07-01 PHASE2
NCT04450407 COMPLETED
Type 1 Diabetes Mellitus
Eli Lilly and Company
2020-07-06 PHASE2
NCT04075513 COMPLETED
Type 1 Diabetes Mellitus
Sanofi
2019-10-09 PHASE4
NCT03740919 COMPLETED
Type 1 Diabetes Mellitus
Eli Lilly and Company
2019-04-07 PHASE3
NCT04569994 COMPLETED
Healthy Volunteers; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2020-09-30 PHASE1
NCT03400501 COMPLETED
Type 1 Diabetes Mellitus
Yale University
2017-10-01 EARLY_PHASE1
NCT04585776 COMPLETED
Type 1 Diabetes
Eli Lilly and Company
2020-10-30 PHASE2
NCT03336528 COMPLETED
Type 2 Diabetes
Emory University
2018-01-02 PHASE4
NCT03952143 COMPLETED
Type 2 Diabetes Mellitus
Eli Lilly and Company
2019-05-27 PHASE3
NCT03377699 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2017-11-22 PHASE3
NCT03882970 COMPLETED
Type 2 Diabetes Mellitus
Eli Lilly and Company
2019-04-01 PHASE3
NCT04276428 COMPLETED
Diabetes Mellitus, Type 2
Eli Lilly and Company
2020-02-28 PHASE1
NCT03987191 COMPLETED
Type 1 Diabetes
University of Colorado, Denver
2020-01-10 PHASE4
NCT03668808 COMPLETED
Diabetes Mellitus, Type 1
Sansum Diabetes Research Institute
2018-11-16 PHASE4
NCT04409587 COMPLETED
Type1 Diabetes Mellitus
Mountain Diabetes and Endocrine Center
2018-04-12 PHASE4
NCT03736785 COMPLETED
Type 2 Diabetes Mellitus
Eli Lilly and Company
2018-11-15 PHASE2
NCT03387787 COMPLETED
Type 2 Diabetes Mellitus
Insel Gruppe AG, University Hospital Bern
2018-01-30 PHASE2; PHASE3
NCT03687827 COMPLETED
Diabetes Mellitus, Type 2
Novo Nordisk A/S
2018-10-02 PHASE4
NCT03938740 COMPLETED
Diabetes Mellitus, Type 1
Diasome Pharmaceuticals
2019-03-18 PHASE2
NCT04190160 COMPLETED
Type2 Diabetes
Stefano Rizza
2018-11-19
NCT03726125 COMPLETED
Healthy
Eli Lilly and Company
2018-11-20 PHASE1
NCT03497260 COMPLETED
Type 1 Diabetes Mellitus; Diabetes Complications
Insel Gruppe AG, University Hospital Bern
2019-01-04
NCT03091712 COMPLETED
Type 2 Diabetes Mellitus
Glooko
2017-05-05
NCT04692415 COMPLETED
Diabetes Mellitus, Type 2
University of Split, School of Medicine
2018-12-15 PHASE4
NCT03172494 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2017-05-26 PHASE3
NCT03838783 UNKNOWN
Type 1 Diabetes Mellitus
LMC Diabetes & Endocrinology Ltd.
2018-05-15 PHASE4
NCT03175120 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2017-05-26 PHASE3
NCT02192450 COMPLETED
Type 1 Diabetes Mellitus; Nocturnal Hypoglycemia; Recurrent Severe Hypoglycaemia
Nordsjaellands Hospital
2015-01 PHASE4
NCT03078478 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2017-03-13 PHASE3
NCT04664764 Unknown status
Type 1 Diabetes Mellitus With Hypoglycemia|type1diabetes
Ain Shams University
2019-02-21 Phase 4
NCT03001323 TERMINATED
Diabetes Mellitus
Hennepin Healthcare Research Institute
2017-01
NCT03268005 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2017-09-19 PHASE3
NCT03736785 Completed
Type 2 Diabetes Mellitus
Eli Lilly and Company
2018-11-15 Phase 2
NCT02501161 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2016-01-31 PHASE3
NCT03674866 Completed
Diabetes Mellitus Type 1|Diabetes Mellitus Type 2
Novo Nordisk A/S
2018-10-29 --
NCT03214367 COMPLETED
Type 1 Diabetes Mellitus
Eli Lilly and Company
2017-07-17 PHASE3
NCT03214380 COMPLETED
Type 2 Diabetes Mellitus
Eli Lilly and Company
2017-07-14 PHASE3
NCT03349840 TERMINATED
Type2 Diabetes
Weill Cornell Medical College in Qatar
2018-01-07 PHASE4
NCT03244241 UNKNOWN
Type 2 Diabetes Mellitus
Merete Bechmann Christensen
2017-04-01 PHASE4
NCT02670915 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2016-05-04 PHASE3
NCT03292185 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2017-09-29 PHASE1
NCT03349840 Terminated
Type2 Diabetes
Weill Cornell Medical College in Qatar|Novo Nordisk A/S
2018-01-07 Phase 4
NCT02607306 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2015-11-18 PHASE3
NCT02964104 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2016-11-15 PHASE1
NCT02911948 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2016-09-21 PHASE3
NCT02967211 COMPLETED
Diabetes Mellitus, Type 2
Sanofi
2015-12-21 PHASE4
NCT02967224 COMPLETED
Diabetes Mellitus, Type 2
Sanofi
2015-11-05 PHASE4
NCT02773368 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2016-05-23 PHASE3
NCT02906917 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2016-09-20 PHASE3
NCT02738151 COMPLETED
Diabetes Mellitus, Type 2
Sanofi
2016-05-19 PHASE4
NCT02500706 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2016-05-04 PHASE3
NCT02762578 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2016-05-03 PHASE3
NCT01959529 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2013-10-29 PHASE3
NCT02420262 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2015-07-26 PHASE3
NCT02844790 COMPLETED
Healthy
Novo Nordisk A/S
2016-07-26 PHASE1
NCT02648217 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2016-01-04 PHASE3
NCT02536859 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2015-08-31 PHASE1
NCT02034513 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2014-01-05 PHASE3
NCT02298192 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2014-11-21 PHASE3
NCT02030600 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2014-01-06 PHASE3
NCT02680457 COMPLETED
Type 2 Diabetes Mellitus
University of Guadalajara
2013-11 PHASE4
NCT02148861 COMPLETED
Diabetes; Type 2 Diabetes Mellitus
Novo Nordisk A/S
2014-05-26 PHASE1
NCT02100475 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2014-04 PHASE3
NCT01835431 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2013-10-17 PHASE3
NCT01952145 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2013-09-20 PHASE3
NCT01849289 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2013-06-02 PHASE3
NCT01880736 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2013-06 PHASE3
NCT01676116 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2012-08-29 PHASE3
NCT01814137 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2013-03 PHASE3
NCT01713530 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2013-02-21 PHASE3
NCT01570751 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2012-04 PHASE3
NCT01664247 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2012-10-01 PHASE3
NCT01916174 COMPLETED
Diabetes; Diabetes Mellitus, Type 2; Healthy
Novo Nordisk A/S
2013-08 PHASE1
NCT01618162 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2012-08-29 PHASE3
NCT01680341 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2012-08-31 PHASE3
NCT01773798 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2013-01 PHASE1
NCT01513473 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2012-01-16 PHASE3
NCT01704417 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2012-10 PHASE1
NCT01513590 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2012-01-16 PHASE3
NCT01569841 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2012-04 PHASE3
NCT01392573 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2011-11-28 PHASE3
NCT01623375 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2012-06 PHASE1
NCT01388361 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2011-09 PHASE3
NCT01590836 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2012-04 PHASE1
NCT01336023 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2011-05-23 PHASE3
NCT01365507 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2011-06 PHASE3
NCT01364428 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2011-06 PHASE3
NCT01455142 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2011-10 PHASE1
NCT01326026 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2011-03 PHASE3
NCT01467414 TERMINATED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2011-10 PHASE1
NCT01437592 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2011-09-06 PHASE1
NCT01272193 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2011-01 PHASE3
NCT01319240 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2011-03 PHASE1
NCT01059812 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-02-01 PHASE3
NCT01059799 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-02-01 PHASE3
NCT00982644 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2009-09 PHASE3
NCT01074268 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2010-02 PHASE3
NCT01076647 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-03 PHASE3
NCT00982228 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-09-01 PHASE3
NCT01068678 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-02 PHASE3
NCT01174303 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2010-08 PHASE1
NCT01068665 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-03 PHASE3
NCT01138488 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2010-06 PHASE1
NCT01079234 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2010-03 PHASE3
NCT01154881 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-06 PHASE1
NCT01193387 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2010-08 PHASE1
NCT01046110 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-01 PHASE3
NCT01134224 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-05 PHASE1
NCT01173926 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2010-07 PHASE1
NCT01135992 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-06 PHASE3
NCT00972283 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2009-09-01 PHASE3
NCT01151072 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2010-06 PHASE1
NCT01135927 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2010-06 PHASE1
NCT01043510 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-01 PHASE1
NCT01045447 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-01 PHASE3
NCT01045707 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2010-01 PHASE3
NCT01006291 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2009-11 PHASE3
NCT01009580 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2009-11-05 PHASE3
NCT01114542 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2010-05-03 PHASE1
NCT01125553 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2010-05 PHASE1
NCT01076634 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2010-02 PHASE1
NCT01030926 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-12 PHASE1
NCT00978627 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-08 PHASE3
NCT01006057 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2009-11 PHASE1
NCT01051102 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2010-01 PHASE1
NCT01002768 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-10 PHASE1
NCT00976326 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2009-08 PHASE1
NCT00992537 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-10 PHASE1
NCT00993096 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-09 PHASE1
NCT00983021 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2009-09 PHASE1
NCT00964418 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-08 PHASE1
NCT00961324 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-07-27 PHASE1
NCT00966368 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2009-08 PHASE1
NCT00964964 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-08 PHASE1
NCT00842361 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2009-01 PHASE2
NCT00841087 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2009-01 PHASE2
NCT01868568 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2008-04 PHASE1
NCT00611884 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2008-01 PHASE2
NCT00613951 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2008-01 PHASE2
NCT01868581 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2008-05 PHASE1
NCT00614055 COMPLETED
Diabetes; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2008-01 PHASE2
NCT00612040 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2008-01 PHASE2
NCT01868529 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2008-01 PHASE1
NCT01868555 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2007-12 PHASE1
NCT01865331 COMPLETED
Diabetes; Healthy
Novo Nordisk A/S
2006-12 PHASE1
NCT01865305 COMPLETED
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2006-09 PHASE1
NCT01865318 COMPLETED
Diabetes; Diabetes Mellitus, Type 1
Novo Nordisk A/S
2006-09 PHASE1
NCT01865292 COMPLETED
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2006-08 PHASE1
NCT01865279 COMPLETED
Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Novo Nordisk A/S
2005-12 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-02-06)

Check the Insulin Degludec product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Insulin degludec binds to the human insulin receptor, activating downstream tyrosine kinase signaling cascades to facilitate glucose transporter translocation in muscle and adipose tissues while suppressing hepatic gluconeogenesis. This protracted receptor activation promotes sustained systemic glucose disposal and glycemic stabilization, providing long-acting therapeutic control essential for managing type 1 and type 2 diabetes mellitus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.