Insulin Glulisine
drugOn this page
Also known as ApidraGlulisine apidraHMR 1964HMR-1964HMR1964Ins apidraIns apidra opticlikIns apidra optisetIns apidra solostarInsulin glulisine recombinantInsulinglulisinehumanInsulina glulisinaInsuline glulisine
Summary
Insulin Glulisine (CHEMBL1201613) is an approved protein (ATC A10AB06); indicated across 6 conditions including diabetes mellitus and type 1 diabetes mellitus.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Protein
- ATC class: A10AB06
- Indications: 6 conditions
- Clinical trials: 73
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201613 |
| Name | Insulin Glulisine |
| Type | Protein |
| Max phase | 4 |
| ATC | A10AB06 |
Also known as: Apidra, Glulisine apidra, HMR 1964, HMR-1964, HMR1964, Ins apidra, Ins apidra opticlik, Ins apidra optiset, Ins apidra solostar, Insulin glulisine, Insulin glulisine recombinant, Insulin
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
6 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| diabetes mellitus | 4 | MONDO:0005015 | EFO:0000400 |
| type 1 diabetes mellitus | 3 | MONDO:0005147 | MONDO:0005147 |
| type 2 diabetes mellitus | 3 | MONDO:0005148 | MONDO:0005148 |
| acute myocardial infarction | 3 | MONDO:0004781 | EFO:0008583 |
| Alzheimer disease | 2 | MONDO:0004975 | MONDO:0004975 |
| Down syndrome | 1 | MONDO:0008608 | EFO:0001064 |
Clinical trials
Total trials: 73.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE4 | 35 |
| PHASE3 | 19 |
| PHASE1 | 11 |
| PHASE2 | 5 |
| Not specified | 3 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00283049 | PHASE4 | TERMINATED | Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control |
| NCT00360698 | PHASE4 | COMPLETED | Insulin Glulisine in Type 2 Diabetic Patients |
| NCT00384085 | PHASE4 | COMPLETED | Insulin Glargine All to Target Trial |
| NCT00489190 | PHASE4 | COMPLETED | APIDRA Registration Study |
| NCT00526513 | PHASE4 | COMPLETED | Study of Safety and Effectiveness of Apidra® in Combination With Basal Insulin in Patients With Type 1 & 2 Diabetes Mellitus |
| NCT00539448 | PHASE4 | COMPLETED | Gulf, Lantus, Apidra Evaluation in Type 1 Diabetics Study |
| NCT00596687 | PHASE4 | COMPLETED | Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery |
| NCT00607087 | PHASE4 | COMPLETED | Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus |
| NCT00913497 | PHASE4 | COMPLETED | The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children |
| NCT00964574 | PHASE4 | COMPLETED | Test of the Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus |
| NCT00965549 | PHASE4 | COMPLETED | Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients |
| NCT01079364 | PHASE4 | TERMINATED | Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting |
| NCT01081938 | PHASE4 | TERMINATED | Insulin Glargine for Diabetes Metabolism(DM)Type II Patients Under Enteral Nutrition |
| NCT01121835 | PHASE4 | COMPLETED | Insulins Glargine and gluLisine strAtegy Versus Premixed Insulin strAteGy: a cOmparative Study |
| NCT01122979 | PHASE4 | COMPLETED | Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure. |
| NCT01131052 | PHASE4 | COMPLETED | Diabetes in the Elderly: Prospective Study |
| NCT01202474 | PHASE4 | COMPLETED | Apidra Children & Adolescents Study |
| NCT01203111 | PHASE4 | COMPLETED | Intensive Insulin Glulisine Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Basal Insulin and Oral Glucose-lowering Drugs |
| NCT01204593 | PHASE4 | COMPLETED | baSal BoluS Therapy in patIenTs With TypE 1 Diabetes Mellitus |
| NCT01212913 | PHASE4 | COMPLETED | Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM) |
| NCT01234597 | PHASE4 | COMPLETED | Evaluation of the Prandial Treatment Adjustment Effect Via Continuous Glucose Monitoring on Type 2 Diabetes Mellitus (DM) Patients Uncontrolled With a Basal Insulin or Premix Once a Day |
| NCT01417897 | PHASE4 | UNKNOWN | Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study |
| NCT01500850 | PHASE4 | UNKNOWN | Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use |
| NCT01594060 | PHASE4 | COMPLETED | Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards |
| NCT01678235 | PHASE4 | COMPLETED | Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus |
| NCT01848990 | PHASE4 | COMPLETED | CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM) |
| NCT02048189 | PHASE4 | TERMINATED | Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes |
| NCT02276196 | PHASE4 | COMPLETED | Effect of LIXIsenatide on the Renal System |
| NCT02276859 | PHASE4 | COMPLETED | Normal Versus Dual Wave Insulin Bolus for High-protein Food |
| NCT02685449 | PHASE4 | UNKNOWN | Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps. |
| NCT02914886 | PHASE4 | COMPLETED | Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS) |
| NCT03328845 | PHASE4 | COMPLETED | Impact on the Oxidative Stress of the Different Analogues of Insulin in People With Type 1 Diabetes. (Ineox Study) |
| NCT03359837 | PHASE4 | COMPLETED | Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy |
| NCT04019821 | PHASE4 | COMPLETED | Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal |
| NCT04124302 | PHASE4 | COMPLETED | The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal. |
| NCT00046150 | PHASE3 | COMPLETED | 12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes. |
| NCT00115570 | PHASE3 | COMPLETED | Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents |
| NCT00135057 | PHASE3 | COMPLETED | Insulin Glulisine in Adult Subjects With Type 2 Diabetes Receiving Insulin Glargine as Basal Insulin |
| NCT00135083 | PHASE3 | COMPLETED | Variable Bolus Regimen 1-2-3 for Type 2 Diabetes Mellitus |
| NCT00135096 | PHASE3 | COMPLETED | Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).