Insulin Detemir
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Insulin Detemir: Autoimmune oophoritis
One-Sentence Summary
Insulin detemir is a long-acting basal insulin analogue, originally used to treat diabetes mellitus and diabetic ketoacidosis. The data compiled for this report include 40 clinical trials and 19 publications on this use.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Autoimmune oophoritis |
| TxGNN Prediction Score | 0.9967 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (1 of 1) – CDSCO approval status is not included in this data |
| Number of Listed Products | 1 (valid: 1) |
| 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 pharmacology, insulin detemir is a soluble, long-acting human insulin analogue. A 14-carbon fatty acid (myristic acid) is attached to the insulin molecule, so it binds reversibly to albumin after injection. This gives slow absorption and a prolonged, more predictable metabolic effect of up to about 24 hours (from the literature compiled for this report).
Type 1 diabetes is defined by absolute insulin deficiency. Insulin detemir binds the insulin receptor and replaces the missing hormone, so it fits the core pathophysiology of the disease. The prediction is therefore best read as confirmation of an existing indication, not as a new repurposing opportunity.
Several lower-ranked predictions (such as pancreatic agenesis) have a similar rationale, but they have no direct clinical or literature evidence in the compiled data.
Clinical Trial Evidence
The compiled data list 40 trials. The most relevant are shown below.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00595374 | Phase 3 | Completed | 114 | Detemir + aspart vs NPH + aspart in adults with type 1 diabetes (Europe); glycaemic control and safety |
| NCT00447382 | Phase 3 | Completed | 330 | 12-month double-blind comparison of detemir from the current vs the NN729 manufacturing process, with aspart as bolus insulin |
| NCT00312156 | Phase 3 | Completed | 347 | Detemir vs NPH, each with aspart, in children and adolescents with type 1 diabetes |
| NCT00184639 | Phase 3 | Completed | 71 | 32-week comparison of detemir vs insulin semilente MC in children, adolescents and young adults |
| NCT00978627 | Phase 3 | Completed | 548 | Insulin degludec/aspart (NN5401) vs detemir + aspart in type 1 diabetes (BOOST: T1) |
| NCT01835431 | Phase 3 | Completed | 362 | Degludec/aspart vs detemir + mealtime aspart in children and adolescents |
| NCT00117780 | Phase 4 | Completed | 520 | Detemir once daily vs twice daily in a basal-bolus regimen with aspart |
| NCT01440439 | Phase 4 | Unknown | 30 | Detemir vs glargine on glycaemic control and metabolism during exercise |
| NCT00322257 | Phase 3 | Terminated | 596 | Inhaled mealtime insulin vs injected aspart, both with detemir as basal insulin; the comparison is not about detemir |
| NCT01542463 | N/A | Completed | 4,464 | Observational documentation of safety, glycaemic control and weight in type 1 or type 2 diabetes |
The remaining trials are mostly large observational safety studies of Levemir and small Phase 1 pharmacokinetic studies.
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) |
| 33662147 | 2021 | Systematic review/meta-analysis | Cochrane Database Syst Rev | (Ultra-)long-acting insulin analogues in type 1 diabetes, with a focus on complications and hypoglycaemia |
| 21878861 | 2011 | Systematic review/meta-analysis | Pol Arch Med Wewn | Detemir vs NPH in type 1 diabetes; benefits not confirmed by all studies |
| 29477399 | 2018 | Systematic review/network meta-analysis | Value Health | Relative efficacy and safety of basal insulin regimens in adults with type 1 diabetes |
| 23243636 | 2012 | Systematic review | Drugs Today (Barc) | Insulin analogues, including detemir, in children and adolescents with type 1 diabetes |
| 17326333 | 2006 | Review | Vasc Health Risk Manag | Detemir is less variable than NPH or ultralente and can reduce hypoglycaemia, especially nocturnal |
| 15516157 | 2004 | Review | Drugs | More predictable, consistent effect than NPH, with less intrapatient variability |
| 20539842 | 2010 | Review | Vasc Health Risk Manag | Detemir offers effective basal therapy with a lower rate of hypoglycaemia |
| 17881328 | 2007 | Review | Endocrinol Metab Clin North Am | Molecular properties and pharmacodynamics of detemir |
| 17881330 | 2007 | Review | Endocrinol Metab Clin North Am | Weight-change data for detemir from trials and observational studies |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 121007 | Levemir 100IU/ml Flexpen (Novo Nordisk India Pvt Ltd) | FlexPen of 3 ml solution for injection | Not stated in the licence data |
Safety Considerations
- Drug Interactions: 353 interactions are recorded. Examples at moderate level include phenylephrine, acebutolol, acetazolamide, formoterol, pseudoephedrine, doxycycline, epinephrine, ethinylestradiol, hydrocortisone, albiglutide, salbutamol, ethanol, hydrochlorothiazide, alogliptin, metformin, pioglitazone, estradiol and alpelisib. Minor-level examples are topical hydrocortisone and topical alclometasone.
- Monitoring suggested by the evidence review: hypoglycaemia, weight changes and injection-site reactions (including localized lipodystrophy with repeated injection).
Please refer to the package insert for warnings and contraindications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Several completed Phase 3 randomised trials and multiple systematic reviews support insulin detemir in type 1 diabetes, which meets the L1 evidence level. However, this is an existing on-label use, so it is not a true repurposing finding. The other nine predicted indications have no supporting clinical or literature data and should stay on Hold, except pancreatic agenesis, which is a reasonable research question as an extension of insulin replacement.
To proceed, the following is needed:
- Package insert warnings and contraindications for the India product (currently missing), and the approved indication text for licence 121007
- Mechanism of action data from DrugBank
- A hypoglycaemia, weight and injection-site monitoring plan
- A review of the 353 recorded drug interactions, especially with other glucose-lowering agents, corticosteroids, beta-blockers and sympathomimetics
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.