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Drug

Insulin degludec

Approved · EMA
Emerging researchLate-stage developmentSteady momentum
Also known as Degludec insulin, Tresiba, Xultophy, Insulina degludec+1 more

Degludec insulin, Tresiba, Xultophy, Insulina degludec, INSULIN,DEGLUDEC,HUMAN/RDNA.

RxNorm1670007UNII54Q18076QB
4
Research papers
8
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Effectiveness and Safety of Once Weekly Insulin Icodec Used With DoseGuide Versus Once Daily Basal Insulin Analogues in an Insulin naïve Type 2 Diabetes Population in a Clinical Practice Setting

Clinical trial2026-06-16Results posted · ClinicalTrials.gov

A 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, in Insulin naïve Subjects With Type 2 Diabetes.

Clinical trial2026-06-12Results posted · ClinicalTrials.gov

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of UBT38006 Injection in Healthy Adult Male Subjects

Clinical trial2026-06-05Results expected Q4 2026 · ClinicalTrials.gov

An I-phase Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics of a Single Dose of HEC-151 Injection in Healthy Chinese Participants in a Single-center, Randomized, Placebo (Single-blind) and Positive Control (Open-label) Study

Clinical trial2026-04-29Results expected Q3 2026 · ClinicalTrials.gov

A Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamics Properties of of SHR-3167 Injection at Steady State in Subjects With Type 2 Diabetes

Clinical trial2026-04-17Results expected Q1 2027 · ClinicalTrials.gov

A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Comparing the Efficacy and Safety of GZR33 Injection and Insulin Degludec Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antidiabetic Drugs

Clinical trial2026-04-07Primary completion · ClinicalTrials.gov

Insulin degludec in a simple or stepwise titration algorithm in a Japanese population of patients with type 2 diabetes: a randomized, 26-week, treat-to-target trial.

Research2016-09-02Diabetology international

Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial.

Research2016-04-01Journal of diabetes investigation

Drug Safety Update: Insulin degludec (Tresiba▼): available in additional higher strength

Regulatory2014-12-11MHRA

Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Patients with Type 2 Diabetes (Begin: Compare).

Research2014-08-01Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists

Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use).

Research2013-06-29Advances in therapy

Approval: Tresiba (EMA)

Regulatory2013-01-20EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Insulin degludec
Aliases & brands
Degludec insulinTresibaXultophyInsulina degludecINSULIN,DEGLUDEC,HUMAN/RDNA
RxNorm CUI
1670007
UNII
54Q18076QB
Regulatory jurisdictions
emamhra

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-01-20
Latest approval
2013-01-20
Authorities
EMA · MHRA
Total events
2
emaEuropean Medicines Agency· 1 event
2013-01-20Approval
Approval: Tresiba (EMA)

Indication: Treatment of diabetes mellitus in adults.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Insulin degludec (Tresiba▼): available in additional higher strength
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

134 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
134
registered trials across all phases
LATEST COMPLETION 2026
8
Active studies
6
Recruiting
73
Late-stage (III+)
123
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 134
Early Phase 11Phase 150Phase 210Phase 2 / 31Phase 356Phase 414Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Clinical Study Comparing Time to Glucose Attainment in Patients With Type 2 Diabetes Mellitus Treated With Degu Insulin Liraglutide Injection Versus Premixed Insulin

Enrolling by invitationPH IVBeijing Tsinghua Chang Gung Hospitaln=1702025

Randomized Controlled Trial Comparing the Safety and Efficacy of Insulin Glargine and Insulin Degludec in Glucocorticoid Induced Hyperglycemia in Hospitalized Patients

CompletedPH IVMax Healthcare Insititute Limitedn=792025

Effect of Glucagon-like Peptide 1 Receptor Agonist in Combination with Insulin on Glycaemic Variability and Time-in-range in Diabetic Kidney Disease: a Randomised Controlled Trial

CompletedPH IVElaine Chown=952024

INHALE-3: A 17-Week Randomized Trial and a 13-Week Extension, Evaluating the Efficacy and Safety of Inhaled Insulin (Afrezza) Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes

CompletedPH IVMannkind Corporationn=1412024

A Randomized Comparison of Transitioning From Insulin GLargine to Insulin Degludec usING a Bridging Dose of Glargine Versus Direct Conversion, in Patients With Type 1 Diabetes Mellitus - a Pilot Study

CompletedPH IVUniversity of Washingtonn=592023

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Study Investigating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes

CompletedPH INovo Nordisk A/Sn=1172026

Pharmacodynamic Properties of Insulin Icodec During Exercise and Prolonged Fasting in Participants With Type 2 Diabetes

CompletedPH INovo Nordisk A/Sn=302025

Randomized Controlled Trial Comparing the Safety and Efficacy of Insulin Glargine and Insulin Degludec in Glucocorticoid Induced Hyperglycemia in Hospitalized Patients

CompletedPH IVMax Healthcare Insititute Limitedn=792025

Effect of Glucagon-like Peptide 1 Receptor Agonist in Combination with Insulin on Glycaemic Variability and Time-in-range in Diabetic Kidney Disease: a Randomised Controlled Trial

CompletedPH IVElaine Chown=952024

A Phase 2 Clinical Trial Comparing the Efficacy and Safety of Once-weekly GZR4 Injection Versus Once-daily Insulin Degludec in Subjects with Type 2 Diabetes Mellitus on OAD Therapy or OAD Therapy in Combination with Basal Insulin

CompletedPH IIGan and Lee Pharmaceuticals, USAn=1792024

A Single and Multiple-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

CompletedPH IEli Lilly and Companyn=662024

Research activity

4 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20132017
Most influential

Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use).

Advances in therapy · 2013 · 40 cites

Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Patients with Type 2 Diabetes (Begin: Compare).

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2014 · 19 cites

Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial.

Journal of diabetes investigation · 2016 · 13 cites

Insulin degludec in a simple or stepwise titration algorithm in a Japanese population of patients with type 2 diabetes: a randomized, 26-week, treat-to-target trial.

Diabetology international · 2017 · 1 cites
Recent papers

Insulin degludec in a simple or stepwise titration algorithm in a Japanese population of patients with type 2 diabetes: a randomized, 26-week, treat-to-target trial.

Diabetology international · 2017 · 1 cites

Efficacy and safety of once-daily insulin degludec dosed flexibly at convenient times vs fixed dosing at the same time each day in a Japanese cohort with type 2 diabetes: A randomized, 26-week, treat-to-target trial.

Journal of diabetes investigation · 2016 · 13 cites

Efficacy and Safety of Insulin Degludec 200 U/mL and Insulin Degludec 100 U/mL in Patients with Type 2 Diabetes (Begin: Compare).

Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2014 · 19 cites

Insulin degludec once-daily in type 2 diabetes: simple or step-wise titration (BEGIN: once simple use).

Advances in therapy · 2013 · 40 cites
Journals, researchers & institutions
Top journals
  • Advances in therapy1
  • Diabetology international1
  • Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists1
  • Journal of diabetes investigation1
Leading researchers
  • Hersløv ML2
  • Hyllested-Winge J2
  • Jinnouchi H2
  • Kadowaki T2
  • Kaku K2
  • Nakamura S2
  • Niemeyer M2
  • Bode BW1
Leading institutions
free-text, unnormalised
  • Graduate School of Medicine and Faculty of Medicine2
  • Jinnouchi Hospital2
  • Kawasaki Medical School2
  • Heiwadai Hospital1
  • Iryo Houjin Shadan Kowakai Heiwadai Hospital1
  • Rainier Clinical Research Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.