Insulin degludec
Highest phase reached
Approved
Drug type
Protein
First approval year
2013
- First approval year
- 2013
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Insulin degludec
- ins tresiba
- Ins tresiba
- insulin degludec component of ryzodeg 70 30
- Insulin degludec component of ryzodeg 70/30
- insulin degludec component of xultophy 100 3 6
- Insulin degludec component of xultophy 100/3.6
- tresiba
- Tresiba
- (1A-21A),(1B-29B)-INSULIN (HUMAN), 29B-(N6-(N-(15-CARBOXY-1-OXOPENTADECYL)-L-.GAMMA.-GLUTAMYL)-L-LYSINE)-
- 1a 21a 1b 29b insulin human 29b n6 n 15 carboxy 1 oxopentadecyl l gamma glutamyl l lysine
- insulin degludec
- Insulin degludec
- Insulin Degludec
- Insulin Degludec - IV
- Insulin Degludec (U-100)
- INSULIN DEGLUDEC [EMA EPAR]
- insulin degludec [INN]
- INSULIN DEGLUDEC [JAN]
- INSULIN DEGLUDEC [ORANGE BOOK]
- INSULIN DEGLUDEC [USAN]
- Insulin degludec [WHO-DD]
- insulin degludec ema epar
- Insulin degludec injection
- Insulin Degludec Injection
- Insulin Degludec Injection (Tresiba®)
- insulin degludec inn
- insulin degludec jan
- insulin degludec orange book
- insulin degludec usan
- insulin degludec who dd
- insulina degludec
- Insulina degludec
- insuline degludec
And 11 more, listed on the interactive page.
- ATC classification codes
- A10AE06
Sources for recorded values
- CAS registry numbers
- 844439-96-9
- ChEMBL ID
- CHEMBL2107869
- PubChem compound IDs
- 118984462
- RxNorm IDs (RxCUI)
- 1670007
- FDA ingredient codes (UNII)
- 54Q18076QB
- Applicant
- NOVO
- Approval date
- 25 Sept 2015
- Application number
- BLA203314
- Status
- Authorised
- Status date
- 20 Jan 2013
- Authorisation date
- 20 Jan 2013
- Approved indications
- Treatment of diabetes mellitus in adults.
- Product number
- EMEA/H/C/002498
- Authorisation holder
- Novo Nordisk A/S
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Diabetes Mellitus
European medicines record
- First in class
- No
- Orphan designation
- No
- Availability
- Prescription only
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Insulin receptor agonist
- Action type
- Agonist
- Target
- Insulin receptor
- Protein identifier
- P06213
Open Targets mechanisms
- Mechanism
- Insulin receptor agonist
- Action type
- Agonist
- Target
- Insulin receptor
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Diabetes Mellitus, Type 1
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0005147
- Subject identifier
- D003922
- Condition
- Diabetes Mellitus, Type 2
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0005148
- Subject identifier
- D003924
- Condition identifier
- EFO_0000400
- Condition identifier
- HP_0001297
- Condition identifier
- HP_0001394
- Highest recorded phase
- 3
- Condition identifier
- HP_0001943
- Highest recorded phase
- 3
- Condition identifier
- HP_0003074
- Condition identifier
- MONDO_0005015
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005068
- Condition identifier
- MONDO_0005147
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005148
- Condition identifier
- MONDO_0005148
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005154
- Condition identifier
- MONDO_0005240
- Condition identifier
- MONDO_0005252
- Condition identifier
- MONDO_0005328
- Condition identifier
- MONDO_0012819
- Highest recorded phase
- 1
- Event
- abdominal transposition
- Reports
- 12
- Reporting signal score
- 67.325
- Event
- blood glucose decreased
- Reports
- 189
- Reporting signal score
- 503.257
- Event
- blood glucose fluctuation
- Reports
- 41
- Reporting signal score
- 96.4104
- Event
- blood glucose increased
- Reports
- 269
- Reporting signal score
- 452.279
- Event
- cardiogenic shock
- Reports
- 50
- Reporting signal score
- 87.4235
- Event
- congenital cardiovascular anomaly
- Reports
- 12
- Reporting signal score
- 45.6815
- Event
- diabetes mellitus inadequate control
- Reports
- 121
- Reporting signal score
- 293.549
- Event
- diabetic ketoacidosis
- Reports
- 162
- Reporting signal score
- 315.493
- Event
- diabetic metabolic decompensation
- Reports
- 21
- Reporting signal score
- 58.3724
- Event
- diabetic neuropathy
- Reports
- 34
- Reporting signal score
- 88.4283
- Event
- diabetic retinopathy
- Reports
- 25
- Reporting signal score
- 63.8057
- Event
- fatigue
- Reports
- 49
- Reporting signal score
- 55.0645
- Event
- foetal disorder
- Reports
- 19
- Reporting signal score
- 59.0698
- Event
- glycosylated haemoglobin increased
- Reports
- 97
- Reporting signal score
- 209.237
- Event
- heart sounds
- Reports
- 6
- Reporting signal score
- 33.542
- Event
- hyperglycaemia
- Reports
- 153
- Reporting signal score
- 267.286
- Event
- hypoglycaemia
- Reports
- 884
- Reporting signal score
- 2,784.43
- Event
- hypoglycaemia neonatal
- Reports
- 37
- Reporting signal score
- 112.796
- Event
- hypoglycaemic coma
- Reports
- 44
- Reporting signal score
- 117.332
- Event
- hypoglycaemic seizure
- Reports
- 10
- Reporting signal score
- 33.062
- Event
- hypoglycaemic unconsciousness
- Reports
- 28
- Reporting signal score
- 91.1622
- Event
- impaired gastric emptying
- Reports
- 35
- Reporting signal score
- 73.248
- Event
- ketoacidosis
- Reports
- 32
- Reporting signal score
- 56.3168
- Event
- lactic acidosis
- Reports
- 74
- Reporting signal score
- 76.0347
- Event
- low birth weight baby
- Reports
- 86
- Reporting signal score
- 206.718
And 11 more, listed on the interactive page.
- NCT00611884
- NCT00613951
- NCT00614055
- NCT00842361
- NCT00972283
- NCT00982644
- NCT01006291
- NCT01009580
- NCT01043510
- NCT01045447
- NCT01045707
- NCT01046110
- NCT01059799
- NCT01059812
- NCT01068665
- NCT01068678
- NCT01076647
- NCT01134224
- NCT01135992
- NCT01154881
- NCT01272193
- NCT01326026
- NCT01336023
- NCT01364428
- NCT01365507
And 119 more, listed on the interactive page.
- Dose
- 10-50 units
- Route
- Subcutaneous
- How often
- Once daily
- Do not administer intravenously or by infusion pump
- Do not dilute or mix with other insulin
- Inject into thigh, upper arm, or abdomen
- Rotate injection sites
- Take with or without food
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence
- Type
- Protein
- Sequence
- FVNQHLCGSHLVEALYLVCGERGFFYTPL
- Component
- Light chain
- Type
- Protein
- Sequence
- GIVEQCCTSICSLYQLENYCN
- 0169-2550
- 0169-2660
- 0169-2662
- 0169-2911
- 73070-400
- 73070-403
- 73070-503
- 50090-3491
- 50090-7094
- 50090-7175
- 50090-7176
Related records
Trials (203)
- A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulin in Patients Already Using Basal Insulin
- A "Real World" Trial to Determine Efficacy and Health Outcomes of Toujeo Compared to "Standard of Care" Basal Insulins in Insulin Naïve Patients Initiating Insulin
- A 104 Week Clinical Trial Comparing Long Term Glycaemic Control of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine Therapy in Subjects With Type 2 Diabetes Mellitus
- A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
- A 38 Week Trial Comparing Effect and Safety of Insulin Degludec/Insulin Aspart vs. Insulin Glargine Plus Insulin Aspart in Subjects With Type 2 Diabetes Treated With Basal Insulin With or Without Oral Antidiabetic Treatment in Need of Treatment Intensification
- A Canadian Study of the Effectiveness of Tresiba® (Insulin Degludec) After Switching Basal Insulin in a Population With Type 1 or Type 2 Diabetes Mellitus
- A Clinical Study Comparing the Pharmacokinetics and Pharmacodynamic Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection (Tresiba®) in Healthy Subjects
- A Clinical Study of GZR33 and GZR101 in Healthy Subjects
- A Clinical Study of Insulin Degludec Injection in Subjects With Type 2 Diabetes
- A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 in Subjects With Type 2 Diabetes
- A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms
- A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
- A Clinical Trial Comparing Glycaemic Control and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Insulin Glargine (IGlar) as add-on Therapy to SGLT2i in Subjects With Type 2 Diabetes Mellitus
- A Comparison Between Two Formulations of NN5401 in Healthy Subjects
- A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs
- A Non-interventional, Post Marketing Surveillance (PMS) Study of Tresiba® (Insulin Degludec) to Evaluate Long Term Safety and Efficacy in Patients With Diabetes Mellitus in Routine Clinical Practice in India
- A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes
- A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
- A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males
- A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
Approved for (1)
In development for (2)
- Type 1 diabetes mellitus Phase 3
- Type 2 diabetes mellitus Phase 3
Targets (1)
- INSR Insulin receptor agonist