Data updated: May 26, 2026
ADMELOG (insulin lispro)
Metabolic
Approved 2017-12-11
ADMELOG is a rapid-acting human insulin analog indicated to improve glycemic control in patients with diabetes mellitus. The medication is approved for use in both adult and pediatric patient populations. It serves as a therapeutic intervention for managing blood sugar levels in individuals requiring insulin supplementation.
How ADMELOG Works
ADMELOG regulates glucose metabolism by lowering blood glucose levels through several biological pathways. It stimulates peripheral glucose uptake in skeletal muscle and fat while simultaneously inhibiting the production of glucose in the liver. Additionally, the drug inhibits the breakdown of fats and proteins and enhances protein synthesis.
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Prescription
- First Approved
- 2017-12-11
- Routes
- INTRAVENOUS, SUBCUTANEOUS
- Dosage Forms
- SOLUTION
ADMELOG Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2017 to 2023
Oct 2018 SUPPL
Mfg
What ADMELOG Treats
1 indicationsADMELOG is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
Source: FDA Label
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Clinical Trial Registry
85 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07109245 | 2025/010 | Ph 4 | recruiting | Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect? |
| NCT06280703 | 18792 J4P-MC-IYAB, U1111-1301-8386 | Ph 1 | recruiting | A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM) |
| NCT07282054 | THDB0206L01 | Ph 3 | completed | Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes |
| NCT04124302 | Mixed Meal Bolus | Ph 4 | completed | The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal. |
| NCT06931041 | CEI-2023/10/04 | Ph 3 | active not recruiting | Comparing Efficacy of Autologous Serum Eye Drops With and Without Insulin in Autoimmune Dry Eye: A Randomized Clinical Trial |
| NCT03660553 results posted | 20180541 | Ph 4 | terminated | Simplified Insulin Regimen for the Elderly |
| NCT04019821 | SuperBolus | Ph 4 | completed | Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal |
| NCT03952130 results posted | 16829 I8B-FH-ITSD | Ph 3 | completed | A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes |
| NCT04816890 | CT041-ADO09 | Ph 2 | completed | A Trial to Assess the Efficacy and Safety of M1 Pram P037 Prandial Insulin in Subjects With Type 1 Diabetes (T1DM) |
| NCT01613807 results posted | SDRI 08-01 F3Z-US-X031 | Ph 4 | completed | Humalog® Mix50/50(tm) as a Treatment for Gestational Diabetes |
| NCT03952143 results posted | 16830 I8B-FH-ITSE | Ph 3 | completed | A Study of LY900014 Compared to Insulin Lispro (Humalog) in Adults With Type 2 Diabetes |
| NCT03740919 PRONTO-Peds results posted | 16698 I8B-MC-ITSB, 2018-002371-18 | Ph 3 | completed | A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes |
| NCT04049123 results posted | 16644 I8B-MC-ITRY | Ph 1 | completed | A Study of LY900014 in Healthy Chinese Participants |
| NCT04276207 results posted | 17277 I8B-MC-ITST, 2019-003493-13 | Ph 1 | completed | A Study of LY900014 Versus Insulin Lispro (Humalog) on High Blood Sugar in Participants With Type 1 Diabetes Who Use Insulin Pumps |
| NCT03338023 results posted | 16036 I4L-GH-ABES | Ph 3 | completed | A Study of LY2963016 Compared to Lantus® in Adult Chinese Participants With Type 1 Diabetes Mellitus |
| NCT02971228 dasiglucagon results posted | ZP4207-16051 | Ph 2 | completed | Feasibility Trial Testing the Bionic Pancreas With ZP4207 |
| NCT03830281 PRONTO-Pump-2 results posted | 16315 I8B-MC-ITRO, 2015-005358-36 | Ph 3 | completed | A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy |
| NCT03760640 results posted | 16917 I8B-MC-ITSM | Ph 2 | completed | A Study of LY900014 in a Medtronic Pump |
| NCT04161976 | 17489 J2H-MC-IUAA, 2019-002318-37 | Ph 1 | completed | A Study of LY900027 Given by Insulin Pump to Participants With Type 1 Diabetes Mellitus |
| NCT03465878 results posted | 16695 I8B-MC-ITSA, 2017-003220-78 | Ph 1 | completed | A Study of LY900014 in Participants With Type 1 Diabetes Mellitus |
| NCT02703324 results posted | 16070 I8B-FW-ITRF, 2015-004705-16 | Ph 1 | completed | A Study of LY900014 Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps |
| NCT02703337 results posted | 16069 I8B-FW-ITRH, 2015-004704-39 | Ph 1 | completed | A Study of LY900014 in Participants With Type 2 Diabetes on Insulin Injection Therapy |
| NCT02703350 results posted | 16068 I8B-FW-ITRG, 2015-004737-27 | Ph 1 | completed | A Study of LY900014 in Participants With Type 1 Diabetes on Insulin Injection Therapy |
| NCT03341312 results posted | 16642 I8B-MC-ITRW, 2017-001501-33 | Ph 1 | completed | A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 2 Diabetes Mellitus (T2DM) |
| NCT02770521 results posted | 16071 I8B-JE-ITRK | Ph 1 | completed | A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants |
| NCT03305822 results posted | 16640 I8B-MC-ITRU, 2017-001305-33 | Ph 1 | completed | A Study of LY900014 in Participants With Type 2 Diabetes Mellitus |
| NCT03341299 results posted | 16641 I8B-MC-ITRV, 2017-001500-30 | Ph 1 | completed | A Comparative Study of LY900014 With Insulin Lispro (Humalog) in Participants With Type 1 Diabetes Mellitus |
| NCT02317575 results posted | 15645 I8B-FW-ITRA | Ph 1 | completed | A Study of LY900014 Formulations in Healthy Participants |
| NCT03407118 results posted | 16645 I8B-MC-ITRZ | Ph 1 | completed | A Study of LY900014 in Japanese Participants With Type 1 Diabetes Mellitus |
| NCT03286751 results posted | 16898 2017-001859-32, I8B-MC-ITSH | Ph 1 | completed | A Comparative Study of LY900014 to Insulin Lispro (Humalog) in Healthy Participants |
| NCT03214367 PRONTO-T1D results posted | 16313 I8B-MC-ITRM, 2015-005356-99 | Ph 3 | completed | A Study of LY900014 in Participants With Type 1 Diabetes |
| NCT03449433 results posted | 16911 I8B-MC-ITSL, 2017-003459-47 | Ph 1 | completed | A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus |
| NCT03166124 results posted | 16637 I8B-MC-ITRR | Ph 1 | completed | A Study of LY900014 in Elderly and Younger Adult Participants With Type 1 Diabetes Mellitus |
| NCT02942654 results posted | 16170 I8B-MC-ITRL | Ph 1 | completed | A Study of LY900014 Formulation in Healthy Participants |
| NCT03214380 PRONTO-T2D results posted | 16314 I8B-MC-ITRN, 2015-005357-12 | Ph 3 | completed | A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes |
| NCT03433677 PRONTO-Pump results posted | 16908 I8B-MC-ITSI, 2017-002374-39 | Ph 3 | completed | A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes |
| NCT01621178 AWARD-7 results posted | 13798 H9X-MC-GBDX, 2012-000829-44 | Ph 3 | completed | A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) |
| NCT02152384 results posted | 15406 I2R-MC-BIDU | Ph 1 | completed | A Study to Compare and Measure the Effects of Insulin Peglispro (LY2605541) and Glargine on Meal Time Insulin Requirements |
| NCT01526733 results posted | Halo-117-401 | Ph 4 | completed | Randomized, Double Blind, 2 Way Crossover Study of CSII With, Versus Without, Pretreatment With Human Hyaluronidase |
| NCT01194245 results posted | HALO-117-205 | Ph 2 | completed | Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus |
| NCT01848990 results posted | Halo-117-403 | Ph 4 | 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) |
| NCT02197520 results posted | 15407 I2R-MC-BIDV | Ph 1 | completed | A Study To Compare the Effects of Insulin Peglispro and Glargine on Insulin Sensitivity and Meal Time Insulin Requirements in Type 2 Diabetics |
| NCT02794155 ISLE-1 | DP 01-2015-01 | Ph 2 | completed | Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1) |
| NCT03509324 | DMT20150410 | Ph 4 | completed | Effectiveness of Glucose Control, β Cell Function in Response to Short-term Insulin Pump Therapy in Type 2 Diabetes |
| NCT01792284 IMAGINE 7 results posted | 14184 I2R-MC-BIAX | Ph 3 | completed | A Study of LY2605541 in Participants With Type 1 Diabetes Mellitus |
| NCT01662921 | APIDRL06229 | Ph 2 | completed | Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes |
| NCT01454284 IMAGINE 3 results posted | 12147 I2R-MC-BIAO, 2011-001253-82 | Ph 3 | completed | A Study in Participants With Type I Diabetes Mellitus |
| NCT01468987 IMAGINE 4 results posted | 12145 I2R-MC-BIAM, 2011-001254-29 | Ph 3 | completed | A Study in Participants With Type 2 Diabetes Mellitus |
| NCT01481779 IMAGINE 1 results posted | 12146 I2R-MC-BIAN, 2011-001261-40 | Ph 3 | completed | A Study in Participants With Type 1 Diabetes Mellitus |
| NCT03367390 | 16679 F3Z-MC-IOQS | Ph 1 | completed | A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM) |
Showing 50 of 85 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADMELOG FDA Label Details
Indications & Usage
FDA Label (PDF)ADMELOG is indicated for the treatment of Diabetes.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.