Data updated: May 26, 2026
TRESIBA (insulin degludec)
Metabolic
Approved 2015-09-25
Tresiba is a long-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients one year of age and older with diabetes mellitus. As a basal insulin, it provides a protracted duration of action for the management of blood glucose levels. This medication is not recommended for the treatment of diabetic ketoacidosis.
How TRESIBA Works
The drug regulates glucose metabolism by stimulating peripheral glucose uptake in skeletal muscle and fat while inhibiting the production of glucose in the liver. Upon subcutaneous injection, insulin degludec forms multi-hexamers that create a localized depot, resulting in a slow and delayed absorption into the systemic circulation. This extended therapeutic effect is further supported by the binding of the insulin analog to circulating albumin.
5
Indications
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Phase 3 Trials
10
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-09-25
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
TRESIBA Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
33 FDA actions from 2015 to 2022 · 3 indication expansions
Jul 2016 SUPPL
Mfg
Jun 2016 SUPPL
Mfg
What TRESIBA Treats
1 indicationsTRESIBA is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
Source: FDA Label
TRESIBA Competitive Set
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MoA expansion candidates
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What's emerging in TRESIBA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRESIBA treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
115 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06685185 | NN1644-7794 2024-511808-17, U1111-1304-2544 | Ph 1 | completed | A Research Study of a New Medicine NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes |
| NCT06280703 | 18792 J4P-MC-IYAB, U1111-1301-8386 | Ph 1 | recruiting | A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) |
| NCT04770532 ONWARDS 2 results posted | NN1436-4478 U1111-1247-4945, 2020-000454-10 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Use Daily Insulin |
| NCT04588259 results posted | NN1218-4357 U1111-1197-8289 | Ph 3 | completed | Research Study to Compare a New Medicine "Fast-acting Insulin Aspart" to Another Medicine "Insulin Aspart" in Chinese People With Diabetes |
| NCT04848480 ONWARDS 6 results posted | NN1436-4625 U1111-1251-7315, 2020-002374-27 | Ph 3 | completed | A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6) |
| NCT06767748 | GZR4-T2D-302 | Ph 3 | active not recruiting | A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin |
| NCT07018453 | SHR-3167-202 | Ph 2 | active not recruiting | A Study Comparing SHR-3167 and Insulin Degludec in Type 2 Diabetic Subjects Treated With Basal Insulin With or Without Oral Antidiabetic Drugs |
| NCT04760626 ONWARDS 5 results posted | NN1436-4481 U1111-1247-5279, 2020-000476-38 | Ph 3 | completed | A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before |
| NCT05463744 QWINT-5 results posted | 18263 I8H-MC-BDCY, 2021-005892-38 | Ph 3 | completed | A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated With Multiple Daily Injection Therapy |
| NCT05275400 results posted | 18237 I8H-MC-BDCU, 2021-002569-16 | Ph 3 | completed | A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 2 Diabetes Currently Treated With Basal Insulin |
| NCT06288412 | NN1436-7615 U1111-1285-1665, 2023-505012-38 | Ph 1 | completed | A Study to Test How a New Long-acting Insulin Works in the Body of Patients With Type 2 Diabetes During Exercise and Prolonged Fasting |
| NCT05362058 QWINT-2 results posted | 18262 I8H-MC-BDCX, 2021-005891-21 | Ph 3 | completed | A Study of Insulin Efsitora Alfa (LY3209590) Compared to Degludec in Adults With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time |
| NCT05243628 ABC results posted | MKC-TI-192 | Ph 4 | completed | Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes |
| NCT04538352 TRANSITION-T2D results posted | 20-853 | Ph 4 | completed | Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D |
| NCT06202079 | GL-GZR-CH2007 | Ph 2 | completed | A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus |
| NCT04795531 ONWARDS 3 results posted | NN1436-4479 U1111-1247-5218, 2020-000472-37 | Ph 3 | completed | 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) |
| NCT05218915 | BGLP-DKD | Ph 4 | completed | Basal Plus GLP1-ra on Glycemic Variability in CKD |
| NCT06556641 | GL-GZR-CH1013 | Ph 1 | completed | A Clinical Study of GZR33 and GZR101 in Healthy Subjects |
| NCT06553248 | GL-GZR-CH1016 | Ph 1 | completed | A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes |
| NCT05904743 | MKC-TI-193 | Ph 4 | completed | INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes |
| NCT06132126 | 18779 J4P-MC-IYAA | Ph 1 | completed | A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus |
| NCT04623086 GLIDING results posted | STUDY00008108 | Ph 4 | completed | Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose |
| NCT03862716 REMITiDegLira | REMITiDegLira | Ph 3 | completed | Remission Evaluation of a Metabolic Intervention for Type 2 Diabetes With IDegLira |
| NCT04569994 | NN1845-4598 U1111-1244-4315, 2019-004658-27 | Ph 1 | completed | A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes |
| NCT03387787 | UDEM_GlucoTab | Ph 2, Ph 3 | completed | Evaluation of Glycaemic Control Using GlucoTab® With Insulin Degludec in Hospitalized Patients With Diabetes Mellitus Type 2 |
| NCT03952130 results posted | 16829 I8B-FH-ITSD | Ph 3 | completed | A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes |
| NCT03377699 EXPECT results posted | NN1250-4300 U1111-1191-3018, 2017-000048-17 | Ph 3 | completed | Research Study Comparing Insulin Degludec to Insulin Detemir, Together With Insulin Aspart, in Pregnant Women With Type 1 Diabetes |
| NCT04663282 | INS068-201 | Ph 2 | completed | A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics |
| NCT03172494 DUAL™ I China results posted | NN9068-4148 U1111-1154-6671, CTR20170004 | Ph 3 | completed | A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs) |
| NCT04450394 results posted | 17056 I8H-MC-BDCL, 2019-003339-53 | Ph 2 | completed | A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus |
| NCT03668808 SafrTravlT1D results posted | ISS-001227 U1111-1210-7350 | Ph 4 | completed | Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones. |
| NCT04450407 results posted | 17183 I8H-MC-BDCP, 2019-003589-41 | Ph 2 | completed | A Study of LY3209590 in Participants With Type 1 Diabetes |
| NCT04585776 results posted | 17601 I8B-MC-ITSZ | Ph 2 | completed | A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes |
| NCT02967224 Reach-Control | LPS13931 2015-001831-18, U1111-1170-8104 | Ph 4 | completed | 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 |
| NCT02967211 REGAIN CONTROL | LPS14060 2015-001832-39, U1111-1170-8132 | Ph 4 | completed | 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 |
| NCT03952143 results posted | 16830 I8B-FH-ITSE | Ph 3 | completed | A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes |
| NCT03740919 PRONTO-Peds results posted | 16698 I8B-MC-ITSB, 2018-002371-18 | Ph 3 | completed | A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes |
| NCT03882970 SURPASS-3 results posted | 16997 I8F-MC-GPGH, 2018-003422-84 | Ph 3 | completed | A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes |
| NCT03078478 CONCLUDE results posted | NN1250-4252 U1111-1184-8175, 2016-002801-20 | Ph 3 | completed | A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs |
| NCT03268005 onset 9 results posted | NN1218-4113 U1111-1180-0636, 2016-000878-38 | Ph 3 | completed | Research Study Comparing a New Medicine "Fast-acting Insulin Aspart" to Another Already Available Medicine "NovoRapid"/"NovoLog" in People With Type 2 Diabetes |
| NCT03328845 INEOX | FIM-EOX-2016-01 | Ph 4 | completed | Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study) |
| NCT02964104 | NN1436-4314 2016-000436-18, U1111-1178-9795 | Ph 1 | completed | A Trial Investigating the Safety, Tolerability, Pharmacokinetics (the Exposure of the Trial Drug in the Body) and Pharmacodynamics (the Effect of the Investigated Drug on the Body) of Insulin 287 in Subjects With Type 2 Diabetes |
| NCT02607306 DUAL™ I Japan results posted | NN9068-4183 U1111-1170-1332, JapicCTI-153089 | Ph 3 | completed | A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese Subjects With Type 2 Diabetes Mellitus. |
| NCT02911948 DUAL™ II Japan results posted | NN9068-4184 U1111-1178-3453, JapicCTI-163385 | Ph 3 | completed | 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 |
| NCT03736785 results posted | 17059 I8H-MC-BDCM | Ph 2 | completed | A Study of LY3209590 in Participants With Type 2 Diabetes Mellitus |
| NCT02148861 | NN1436-4057 2013-001180-22, U1111-1140-5344 | Ph 1 | completed | A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered NNC0148-0287 (Insulin 287) in Subjects With Type 2 Diabetes |
| NCT03687827 SWITCH PRO results posted | NN1250-4419 U1111-1203-0580, 2017-004047-20 | Ph 4 | completed | A Research Study to Compare the Effect of Insulin Degludec and Insulin Glargine on Blood Sugar Levels in People With Type 2 Diabetes - the SWITCH PRO Study |
| NCT04276428 | 16983 I8H-JE-BDCK | Ph 1 | completed | A Study of LY3209590 in Japanese Participants With Type 2 Diabetes Mellitus |
| NCT02680457 Diabetes results posted | CT-DG-140282-JLRN | Ph 4 | completed | Effect of Insulin Degludec Versus Insulin Glargine on Glycemic Variability in Patients With Type 2 Diabetes Mellitus |
| NCT03214367 PRONTO-T1D results posted | 16313 I8B-MC-ITRM, 2015-005356-99 | Ph 3 | completed | A Study of LY900014 in Participants With Type 1 Diabetes |
Showing 50 of 115 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRESIBA FDA Label Details
Indications & Usage
FDA Label (PDF)TRESIBA is indicated for the treatment of Diabetes.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.