TRIAL RESULTS · SIDE EFFECTS
Insulin degludec side effects
ANSWER
27 trials of Insulin degludec posted side-effect results, none against placebo, so no placebo rate exists to compare. Most reported: nasopharyngitis, upper respiratory tract infection, diarrhoea. Read from ClinicalTrials.gov on 2026-10-03. Not medical advice.
Trial register
Trials with posted results
27
with an arm on Insulin degludec, of 255 registered
Against placebo
0
placebo-controlled trials
People in those trials
0
on Insulin degludec · 0 on placebo
Read
2026-10-03
ClinicalTrials.gov
ALL TRIALS
The 100 most reported of 1366 side effects reported
Every trial with posted results and an arm on Insulin degludec (n ≥ 20), all phases, by people affected. Placebo is shown where placebo-controlled trials reported the same event. Comparator arms are not counted.
| Side effect | Organ system | Insulin degludec | Placebo | Trials |
|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 9.5% (468 of 4,903) | - | 13 |
| Upper respiratory tract infection | Infections and infestations | 4.8% (420 of 8,686) | - | 14 |
| Diarrhoea | Gastrointestinal disorders | 2.7% (258 of 9,478) | - | 16 |
| Viral upper respiratory tract infection | Infections and infestations | 32.0% (242 of 756) | - | 2 |
| Headache | Nervous system disorders | 2.5% (206 of 8,094) | - | 13 |
| Diabetic retinopathy | Eye disorders | 2.7% (196 of 7,245) | - | 10 |
| Nausea | Gastrointestinal disorders | 2.0% (141 of 6,980) | - | 10 |
| Cardiac failure congestive | Cardiac disorders | 2.2% (138 of 6,347) | - | 7 |
| Acute myocardial infarction | Cardiac disorders | 1.2% (121 of 9,704) | - | 18 |
| Influenza | Infections and infestations | 1.6% (120 of 7,392) | - | 9 |
| Lipase increased | Investigations | 5.2% (113 of 2,182) | - | 5 |
| Pneumonia | Infections and infestations | 1.1% (107 of 9,951) | - | 18 |
| Hypoglycaemia | Metabolism and nutrition disorders | 1.1% (107 of 9,315) | - | 17 |
| Covid-19 | Infections and infestations | 6.3% (103 of 1,628) | - | 5 |
| Angina unstable | Cardiac disorders | 1.3% (100 of 7,414) | - | 9 |
| COVID-19 | Infections and infestations | 11.4% (97 of 849) | - | 3 |
| Coronary artery disease | Cardiac disorders | 1.2% (95 of 7,612) | - | 11 |
| Urinary tract infection | Infections and infestations | 1.2% (79 of 6,519) | - | 8 |
| Back pain | Musculoskeletal and connective tissue disorders | 1.3% (78 of 5,883) | - | 6 |
| Acute kidney injury | Renal and urinary disorders | 1.3% (73 of 5,585) | - | 6 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1.1% (63 of 5,791) | - | 7 |
| Fall | Injury, poisoning and procedural complications | 1.0% (62 of 6,469) | - | 8 |
| Cellulitis | Infections and infestations | 0.8% (58 of 7,705) | - | 10 |
| Constipation | Gastrointestinal disorders | 1.0% (58 of 5,975) | - | 7 |
| Drug titration error | Injury, poisoning and procedural complications | 11.9% (55 of 462) | - | 1 |
| Myocardial infarction | Cardiac disorders | 0.7% (54 of 7,618) | - | 11 |
| Non-cardiac chest pain | General disorders | 0.8% (54 of 6,497) | - | 8 |
| Hypoglycaemic unconsciousness | Nervous system disorders | 0.7% (52 of 7,311) | - | 9 |
| Ischaemic stroke | Nervous system disorders | 0.7% (50 of 6,745) | - | 8 |
| Atrial fibrillation | Cardiac disorders | 0.8% (50 of 6,467) | - | 7 |
| Decreased appetite | Metabolism and nutrition disorders | 0.9% (50 of 5,373) | - | 5 |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | 0.7% (46 of 6,239) | - | 7 |
| Hypertension | Vascular disorders | 0.8% (46 of 5,564) | - | 6 |
| Blood glucose decreased | Investigations | 1.2% (46 of 3,948) | - | 2 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 0.7% (45 of 6,872) | - | 8 |
| Weight increased | Investigations | 4.3% (43 of 1,008) | - | 2 |
| Angina pectoris | Cardiac disorders | 0.7% (42 of 6,177) | - | 6 |
| Sepsis | Infections and infestations | 0.5% (40 of 7,828) | - | 11 |
| Viral Upper Respiratory Tract Infection | Infections and infestations | 8.7% (40 of 462) | - | 1 |
| Vomiting | Gastrointestinal disorders | 0.5% (37 of 7,173) | - | 10 |
| Transient ischaemic attack | Nervous system disorders | 0.5% (31 of 6,854) | - | 8 |
| Syncope | Nervous system disorders | 0.5% (29 of 5,698) | - | 6 |
| Cardiac failure | Cardiac disorders | 0.4% (28 of 7,210) | - | 9 |
| Osteomyelitis | Infections and infestations | 0.4% (27 of 7,111) | - | 9 |
| Death | General disorders | 0.6% (27 of 4,611) | - | 3 |
| Cardiac arrest | Cardiac disorders | 0.5% (26 of 5,146) | - | 4 |
| Pharyngitis | Infections and infestations | 0.6% (26 of 4,364) | - | 2 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 0.5% (25 of 5,194) | - | 5 |
| Dehydration | Metabolism and nutrition disorders | 0.5% (25 of 5,075) | - | 4 |
| Pyrexia | General disorders | 0.5% (25 of 4,694) | - | 4 |
| Road traffic accident | Injury, poisoning and procedural complications | 0.3% (24 of 6,882) | - | 8 |
| Eczema | Skin and subcutaneous tissue disorders | 0.5% (23 of 4,364) | - | 2 |
| Chest pain | General disorders | 0.4% (22 of 6,055) | - | 7 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 0.4% (22 of 4,931) | - | 4 |
| Hyperlipidaemia | Metabolism and nutrition disorders | 4.1% (22 of 533) | - | 1 |
| Bronchitis | Infections and infestations | 0.3% (20 of 6,430) | - | 7 |
| Peripheral arterial occlusive disease | Vascular disorders | 0.3% (19 of 6,153) | - | 6 |
| Upper Respiratory Tract Infection | Infections and infestations | 4.1% (19 of 462) | - | 1 |
| Hyperkalaemia | Metabolism and nutrition disorders | 0.5% (18 of 3,818) | - | 1 |
| Carotid artery stenosis | Nervous system disorders | 0.4% (17 of 4,774) | - | 4 |
| Nephrolithiasis | Renal and urinary disorders | 0.2% (16 of 6,638) | - | 7 |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | 0.3% (16 of 5,555) | - | 6 |
| Renal failure | Renal and urinary disorders | 0.3% (16 of 5,289) | - | 4 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 0.4% (16 of 4,509) | - | 3 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 3.3% (16 of 484) | - | 2 |
| Chronic kidney disease | Renal and urinary disorders | 0.4% (16 of 3,818) | - | 1 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 0.2% (15 of 7,356) | - | 11 |
| Abdominal pain | Gastrointestinal disorders | 0.3% (15 of 5,469) | - | 5 |
| Cerebrovascular accident | Nervous system disorders | 0.3% (15 of 5,780) | - | 5 |
| Diverticulitis | Infections and infestations | 0.3% (15 of 5,773) | - | 5 |
| Gastroenteritis | Infections and infestations | 0.3% (15 of 5,322) | - | 5 |
| Dose calculation error | Injury, poisoning and procedural complications | 4.5% (15 of 331) | - | 1 |
| Cholecystitis acute | Hepatobiliary disorders | 0.2% (14 of 6,442) | - | 8 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 0.2% (14 of 6,921) | - | 8 |
| Coronary artery stenosis | Cardiac disorders | 0.2% (14 of 5,679) | - | 6 |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0.3% (14 of 5,452) | - | 5 |
| Abdominal discomfort | Gastrointestinal disorders | 0.3% (14 of 4,696) | - | 4 |
| Hypotension | Vascular disorders | 0.3% (14 of 4,110) | - | 2 |
| Skin ulcer | Skin and subcutaneous tissue disorders | 0.3% (14 of 4,178) | - | 2 |
| Cholelithiasis | Hepatobiliary disorders | 0.2% (13 of 7,568) | - | 11 |
| Cardio-respiratory arrest | Cardiac disorders | 0.2% (13 of 5,309) | - | 5 |
| Anaemia | Blood and lymphatic system disorders | 0.3% (13 of 4,678) | - | 4 |
| Deep vein thrombosis | Vascular disorders | 0.3% (13 of 5,180) | - | 4 |
| Coronary artery occlusion | Cardiac disorders | 0.3% (13 of 4,995) | - | 3 |
| Acute coronary syndrome | Cardiac disorders | 0.2% (12 of 5,711) | - | 5 |
| Cataract | Eye disorders | 0.2% (12 of 5,224) | - | 5 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 0.2% (12 of 5,865) | - | 5 |
| Hyperglycaemia | Metabolism and nutrition disorders | 0.3% (12 of 4,722) | - | 4 |
| Postoperative wound infection | Infections and infestations | 0.2% (12 of 4,951) | - | 3 |
| Septic shock | Infections and infestations | 0.3% (12 of 4,509) | - | 3 |
| Atrial flutter | Cardiac disorders | 0.3% (12 of 4,149) | - | 2 |
| Peripheral vascular disorder | Vascular disorders | 0.3% (12 of 4,489) | - | 2 |
| End stage renal disease | Renal and urinary disorders | 0.3% (12 of 3,818) | - | 1 |
| Myocardial ischaemia | Cardiac disorders | 0.2% (11 of 6,098) | - | 6 |
| Diabetic foot | Skin and subcutaneous tissue disorders | 0.2% (11 of 5,147) | - | 5 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0.2% (11 of 4,632) | - | 3 |
| Urosepsis | Infections and infestations | 0.2% (11 of 4,574) | - | 3 |
| Gastritis | Gastrointestinal disorders | 0.2% (10 of 5,788) | - | 6 |
| Cardiac failure chronic | Cardiac disorders | 0.2% (10 of 5,188) | - | 4 |
| Ventricular tachycardia | Cardiac disorders | 0.2% (10 of 5,303) | - | 4 |
Source: ClinicalTrials.gov posted results, read 2026-10-03. A trial lists events above its own reporting threshold, so a rare event may be missing from some trials. Not medical advice.
FDA LABEL
What the FDA label says
Xultophy 100/3.6 BLA208583 · label of 2025-10-14 Regulator
Most common adverse reactions (incidence ≥5%) in clinical trials are nasopharyngitis, headache, nausea, diarrhea, increased lipase and upper respiratory tract infection.
REGISTERED STUDIES
255 registered clinical trials of Insulin degludec
The 10 most recently updated are listed.
| NCT07630233 | A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous UBT38006 Injection in Healthy Adult Males Status: RECRUITING · Updated 2026-09-15 |
|---|---|
| NCT05220917 | Comparative Effectiveness and Safety of Four Second Line Pharmacological Strategies in Type 2 Diabetes Study Status: ACTIVE_NOT_RECRUITING · Updated 2026-08-13 |
| NCT04760626 | 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 Status: COMPLETED · Updated 2026-08-11 |
| NCT06238778 | Phase 2b Trial Comparing HDV-Insulin Lispro to Insulin Lispro in Adults With Type 1 Diabetes Receiving Insulin Degludec Status: COMPLETED · Updated 2026-07-31 |
| NCT07652528 | CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial Status: NOT_YET_RECRUITING · Updated 2026-07-22 |
| NCT07215312 | A Study of LY3938577 in Participants With Type 2 Diabetes Previously Treated With Basal Insulin Status: ACTIVE_NOT_RECRUITING · Updated 2026-07-13 |
| NCT07527078 | Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes Status: RECRUITING · Updated 2026-07-01 |
| NCT04795531 | 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) Status: COMPLETED · Updated 2026-06-12 |
| NCT06288412 | 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 Status: COMPLETED · Updated 2026-06-08 |
| NCT07599891 | Comparing the Safety and Efficacy of Insulin GLARGINE and DEGLUDEC in Glucocorticoid Induced HYPERGLYCEMIA in Hospitalized Patients". Status: COMPLETED · Updated 2026-05-20 |
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.