Insulin Glulisine
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
- Insulin Glulisine
- Insulin Glulisine: From Diabetes Mellitus (Glycemic Control) to Type 1 Diabetes Mellitus
Insulin Glulisine: From Diabetes Mellitus (Glycemic Control) to Type 1 Diabetes Mellitus
One-Sentence Summary
Insulin glulisine (Apidra) is a rapid-acting human insulin analogue used at mealtimes to improve glycemic control in diabetes. The TxGNN model predicts it is effective for type 1 diabetes mellitus, with over 40 registered clinical trials and 16 publications in the evidence pack. This prediction largely confirms an existing use of the drug rather than a new repurposing finding.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the supplied license data. Literature describes glycemic control in adults, adolescents and children with diabetes mellitus |
| Predicted New Indication | Type 1 diabetes mellitus |
| TxGNN Prediction Score | 99.55% |
| Evidence Level | L1 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 2 listings (both under BLA021629) |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the evidence pack. Insulin glulisine is a rapid-acting insulin analogue that acts on the insulin receptor to replace mealtime (prandial) insulin. Published reviews describe it as having a faster onset and shorter duration of action than regular human insulin.
Type 1 diabetes is defined by absolute insulin deficiency, so the mechanistic link is direct. The high TxGNN score (99.55%) matches what the drug is already used for.
Guardrail: The empty original-indication field and missing mechanism data look like gaps in the dataset, not a true repurposing signal. Treat this result as confirmation of an existing use.
Clinical Trial Evidence
The pack lists more than 40 trials. The 10 most relevant are shown below. Enrollment and status come from the registry entries.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT00467376 | Phase 3 | Completed | 485 | Glulisine vs lispro with glargine in type 1 or 2 diabetes. Compares efficacy, safety and hypoglycemia frequency |
| NCT00546702 | Phase 3 | Completed | 142 | Open-label, non-randomized study of glulisine plus glargine in type 1 diabetes over 26 weeks. Primary outcome is HbA1c change |
| NCT00046150 | Phase 3 | Completed | 59 | Safety of glulisine (HMR1964) vs insulin aspart in insulin pumps (CSII) in type 1 diabetes. Focus on catheter occlusions and hypoglycemia |
| NCT07070752 | Phase 3 | Completed | 224 | Non-inferior immunogenicity of the biosimilar GP40321 vs Apidra SoloStar in type 1 diabetes |
| NCT00135941 | Phase 3 | Completed | 582 | Glargine plus glulisine multiple daily injections vs premix insulin in type 1 or 2 diabetes. Outcome is patient-reported outcomes |
| NCT00539448 | Phase 4 | Completed | 98 | Non-comparative study of glargine plus glulisine in type 1 diabetes. HbA1c change over 26 weeks |
| NCT00489190 | Phase 4 | Completed | 45 | Local study of the effectiveness and tolerability of Apidra over 12 weeks in type 1 diabetes |
| NCT00925977 | NA | Terminated | 44 | Treatment satisfaction with glargine vs NPH, each plus Apidra, in children and adolescents with newly diagnosed type 1 diabetes |
| NCT02914886 | Phase 4 | Completed | 14 | Whether glulisine (a zinc-free insulin) helps lipoatrophy in type 1 diabetes patients on insulin pumps |
| NCT00297583 | Phase 1 | Completed | Not reported | Glulisine vs lispro vs human insulin on endogenous glucose production in type 1 diabetes (glucose clamp) |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 16308840 | 2005 | RCT | Horm Metab Res | Multinational open-label RCT of glulisine vs lispro in adults with type 1 diabetes (683 randomized). This is the pivotal efficacy and safety study |
| 21457066 | 2011 | RCT | Diabetes Technol Ther | Three-way crossover of glulisine vs aspart vs lispro in insulin pumps in type 1 diabetes |
| 21291333 | 2011 | Clinical trial | Diabetes Technol Ther | Comparable efficacy and safety of glulisine and lispro in a 26-week basal-bolus regimen in children and adolescents with type 1 diabetes |
| 41366610 | 2026 | RCT | Diabetes Obes Metab | Phase 3 RCT of a biosimilar glulisine vs the originator in adults with type 1 diabetes. Assessed immunogenicity, efficacy and safety |
| 19614947 | 2009 | Clinical trial | Diabetes Obes Metab | Glulisine vs lispro with glargine in Japanese patients with type 1 diabetes |
| 35933650 | 2022 | Comparative study | Acta Diabetol | Glulisine vs lispro and aspart in insulin pumps in type 1 diabetes. Compared HbA1c, fasting glucose, dose, and rates of hypo/hyperglycemia and ketoacidosis |
| 19496630 | 2009 | Review | Drugs | Glulisine is approved to improve glycemic control in adults, adolescents and children. Efficacy is similar to lispro and non-inferior to other short- and rapid-acting insulins |
| 16123473 | 2005 | PK/PD study | Diabetes Care | Pharmacokinetics, postprandial glucose control and safety vs regular human insulin in children and adolescents with type 1 diabetes |
| 28544684 | 2017 | Clinical study | Pediatr Int | One year of pump use in 20 children with type 1 diabetes. Post-meal glucose improved significantly |
| 18076215 | 2008 | Review | Clin Pharmacokinet | Clinical pharmacokinetics and pharmacodynamics. Faster absorption and shorter duration of action than regular human insulin |
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| BLA021629 | Apidra SoloStar | Injection, solution | sanofi-aventis U.S. LLC |
| BLA021629 | Apidra | Injection, solution | sanofi-aventis U.S. LLC |
Both listings fall under the same BLA. The approved-indication text is not included in the supplied data.
Safety Considerations
Please refer to the package insert for safety information.
The lower-ranked predictions (drug-induced localized lipodystrophy, pressure-induced localized lipoatrophy) most likely reflect injection-site lipohypertrophy or lipoatrophy from injected insulin. Treat these as safety flags, not new indications.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Several completed Phase 3 trials and RCTs support glulisine in type 1 diabetes, and the drug is already marketed in the US. The result is best read as confirmation of an existing indication, not a novel repurposing opportunity. The other nine predictions (ranks 2–10) have no supporting trials or literature. All are held, except pancreatic agenesis, which is marked a research question.
To proceed, the following is needed:
- The FDA package insert (approved indication, warnings, contraindications). Without it, S1 safety screening cannot proceed.
- Mechanism-of-action data from DrugBank.
- Verification of the intervention identity in trials with truncated or unconfirmed titles, including NCT07070752 (biosimilar immunogenicity endpoint).
- A targeted literature search on pancreatic agenesis to confirm standard-of-care status.
This report is for research reference only and does not constitute medical advice. Repurposing candidates require clinical validation before use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.