Insulin Degludec
| Evidence Level: L5 | Predicted Indications: 5 |
Table of Contents
Insulin Degludec: Autoimmune oophoritis
One-Sentence Summary
Insulin degludec is an ultra-long-acting basal insulin analogue, originally used to treat diabetes mellitus and diabetic ketoacidosis. This is effectively an on-label use rather than true repurposing.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Autoimmune oophoritis |
| TxGNN Prediction Score | 0.9923 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (4 of 4) – CDSCO approval status is not included in this data |
| Number of Listed Products | 4 (valid: 4) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data are not available in the data compiled for this report. Based on known information, insulin degludec is a long-acting basal insulin analogue that replaces deficient endogenous insulin by activating the insulin receptor. Its half-life is about 25 hours and its duration of action exceeds 42 hours, giving a flat, stable glucose-lowering profile.
Type 1 diabetes is the core indication for insulin therapy, because people with this condition cannot produce enough insulin. The original indication (diabetes mellitus) already covers it, so the high TxGNN score is consistent with the established mechanism. Degludec has also been studied directly in type 1 diabetes in switching studies, pregnancy, exercise and paediatric populations.
Other predicted indications (autoimmune oophoritis, opsismodysplasia, thiamine-responsive dysfunction syndrome, focal stiff limb syndrome, classic stiff person syndrome) have no clinical trials or literature.
Clinical Trial Evidence
The data include 40 trials. The most relevant are listed below, with completed Phase 3 trials and trials that use degludec directly prioritised.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT02034513 | Phase 3 | Completed | 501 | SWITCH 1: degludec vs insulin glargine, both with insulin aspart, double-blind crossover in type 1 diabetes |
| NCT05463744 | Phase 3 | Completed | 692 | Weekly insulin efsitora alfa vs degludec in type 1 diabetes on multiple daily injections |
| NCT02500706 | Phase 3 | Completed | 1108 | Faster-acting insulin aspart vs NovoRapid, both with degludec, in adults with type 1 diabetes |
| NCT02670915 | Phase 3 | Completed | 834 | Faster-acting insulin aspart vs NovoRapid, both with degludec, in children and adolescents |
| NCT01835431 | Phase 3 | Completed | 362 | Degludec/aspart once daily vs insulin detemir in children and adolescents with type 1 diabetes |
| NCT00978627 | Phase 3 | Completed | 548 | Degludec/aspart plus aspart vs detemir plus aspart in type 1 diabetes (BOOST T1) |
| NCT03952130 | Phase 3 | Completed | 354 | LY900014 vs insulin lispro with glargine or degludec as basal insulin (indirect evidence for degludec) |
| NCT01569841 | Phase 3 | Completed | 24 | Degludec vs glargine on glycaemic control using continuous glucose monitoring |
| NCT04075513 | Phase 4 | Completed | 343 | Glargine 300 U/ml vs degludec 100 U/ml on glycaemic control and variability with continuous glucose monitoring |
| NCT00612040 | Phase 2 | Completed | 178 | Two degludec formulations vs glargine in a basal/bolus regimen in type 1 diabetes |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 36623517 | 2023 | RCT | Lancet Diabetes Endocrinol | EXPECT: degludec vs detemir, both with aspart, in pregnant women with type 1 diabetes (non-inferiority) |
| 37863084 | 2023 | RCT | Lancet | ONWARDS 6: once-weekly icodec vs once-daily degludec in adults with type 1 diabetes |
| 39270686 | 2024 | RCT | Lancet | QWINT-5: once-weekly efsitora alfa vs degludec in adults with type 1 diabetes (non-inferiority) |
| 40903851 | 2025 | RCT | Diabetes Obes Metab | Early degludec added to intravenous insulin infusion in diabetic ketoacidosis management |
| 36763996 | 2022 | Systematic review / meta-analysis | Clin Ther | Efficacy and tolerability of degludec vs other long-acting basal analogues in type 1 and type 2 diabetes |
| 33662147 | 2021 | Systematic review | Cochrane Database Syst Rev | (Ultra-)long-acting insulin analogues for type 1 diabetes |
| 35476308 | 2022 | Systematic review | Int J Clin Pharm | Indirect comparison of degludec U100 vs glargine U300 in type 1 diabetes: safety, efficacy and cost-effectiveness |
| 29477399 | 2018 | Systematic review / network meta-analysis | Value Health | Relative efficacy and safety of basal insulin regimens in adults with type 1 diabetes |
| 35147781 | 2022 | Real-world study | Acta Diabetol | Pregnancy outcomes in women with type 1 diabetes using degludec vs other long-acting analogues |
| 23620200 | 2013 | Review | Drugs | Review of degludec and degludec/aspart: flat, stable profile with lower day-to-day variability than glargine |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 184174 | Ryzodeg 100IU/ml Flextouch | Pre-filled pen of 3 ml solution for injection | Not stated |
| 214868 | Tresiba 100 Units/ml Penfill | Penfill of 3 ml solution for injection | Not stated |
| 214903 | Tresiba 100IU/ml Flextouch | Pre-filled pen of 3 ml solution for injection | Not stated |
| 184148 | Ryzodeg 100IU/ml Penfill | Penfill of 3 ml solution for injection | Not stated |
All four registrations are valid products from Novo Nordisk India Pvt Ltd.
Review correction (2026-11-06): Originally stated: “All four registrations are valid, single-ingredient products from Novo Nordisk India Pvt Ltd.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.
Safety Considerations
- Drug Interactions: 351 interactions were recorded. Most listed examples are moderate:
- Other glucose-lowering drugs: metformin, pioglitazone, alogliptin, albiglutide (additive hypoglycaemia risk is the likely concern)
- Beta-agonists and sympathomimetics: salbutamol, formoterol, epinephrine, phenylephrine, pseudoephedrine
- Corticosteroids, hormones and others: hydrocortisone, estradiol, levonorgestrel, norethisterone, hydrochlorothiazide, doxycycline, ethanol, acebutolol, alpelisib
- Topical hydrocortisone and topical alclometasone are rated minor.
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Several completed Phase 3 RCTs and multiple systematic reviews support degludec in type 1 diabetes, and the product is already marketed in India. Because this is on-label use, the question is mainly confirmation and safety management, not new efficacy.
To proceed, the following is needed:
- Package insert warnings and contraindications from the Indian regulator, which are currently missing and block safety screening
- Detailed mechanism of action data, to complete the mechanistic analysis
- A hypoglycaemia monitoring plan, with attention to interactions with other glucose-lowering drugs
- Approved indication wording for the four Indian registrations, to confirm type 1 diabetes is explicitly covered
Review Log
Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.
| Review date | Item | Action | Source |
|---|---|---|---|
| 2026-11-06 | Removed: “single-ingredient” | Corrected | Indian Medicine Dataset |
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.