Data updated: May 26, 2026
Toujeo (insulin glargine)
Approved 2015-02-24
1
Indication
--
Phase 3 Trials
11
Years on Market
Details
- Status
- Prescription
- First Approved
- 2015-02-24
- Revenue
- $367M (Q4-2025)
- Routes
- Subcutaneous
- Dosage Forms
- Injection
Toujeo Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2015 to 2015
Feb 2015 ORIGINAL
Update · CBER biologic (Purple Book)
What Toujeo Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- Other (1)
Other
(1 approval)- • Approved indication (Feb 2015)
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Clinical Trial Registry
191 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05803421 ACHIEVE-4 | 18563 J2A-MC-GZGS, 2022-502833-25-00 | Ph 3 | completed | A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk |
| NCT06340854 | NN1436-7724 U1111-1292-6151, 2023-506084-34 | Ph 3 | completed | A Research Study to See How Switching From a Daily Basal Insulin to a New Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine in Adults With Type 2 Diabetes |
| NCT06269107 COMBINE 4 | NN1535-4988 U1111-1283-8648, 2022-502484-38-00 | Ph 3 | completed | A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4) |
| NCT07076199 ONWARDS 11 | NN1436-8182 U1111-1310-7017, 2024-519945-31 | Ph 3 | recruiting | A Research Study to See How a Weekly Insulin, Insulin Icodec, Helps in Reducing the Blood Sugar Compared to Daily Insulin Glargine, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes |
| NCT07461103 | 0108172 | Ph 2 | completed | Effect of Topical Insulin on Healing Rate of Pemphigus Lesions |
| NCT06881264 | HR17031-301 | Ph 3 | completed | A Study Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes |
| NCT06871761 | HR17031-302 | Ph 3 | completed | A Trial Comparing HR17031 With Insulin Glargine in Patients With Type 2 Diabetes |
| NCT07282054 | THDB0206L01 | Ph 3 | completed | Efficacy and Safety of THDB0206 Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes |
| NCT04460885 ONWARDS 1 results posted | NN1436-4477 U1111-1247-3878, 2020-000442-34 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before |
| NCT04880850 ONWARDS 4 results posted | NN1436-4480 U1111-1247-5269, 2020-000474-16 | Ph 3 | completed | A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4) |
| NCT05013229 | NN1535-4593 U1111-1260-8295, 2020-005309-18 | Ph 3 | completed | A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3) |
| NCT06688123 | SHR-3167-201 | Ph 2 | active not recruiting | Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects |
| NCT06370715 | 18269 I8B-MC-ITTA | Ph 4 | completed | A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India |
| NCT05614089 HumAn-1 results posted | STUDY21110122 | Ph 4 | completed | Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings |
| NCT05662332 QWINT-1 results posted | 18261 I8H-MC-BDCW | Ph 3 | completed | A Study of Insulin Efsitora Alfa (LY3209590) Compared to Glargine in Adult Participants With Type 2 Diabetes Who Are Starting Basal Insulin for the First Time (QWINT-1) |
| NCT05098470 | 210395 R01DK029953 | Ph 3 | active not recruiting | Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity |
| NCT05780151 RADIAL | EU-CT number 2022-500449-26-00 1006010 | Ph 4 | completed | Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL) |
| NCT05702073 | INS068-301 | Ph 3 | completed | To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin. |
| NCT05699408 | INS068-302 | Ph 3 | completed | To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs |
| NCT03087032 LiraGooD | KYH2017-002 | Ph 4 | recruiting | Liraglutide-bolus vs Glargine-bolus Therapy in Overweight/Obese Type 2 Diabetes Patients (LiraGooD) |
| NCT06619301 | 217918 | Ph 3 | recruiting | RCT Glargine vs NPH for Treatment of DM in Pregnancy |
| NCT06007508 | X1935200 | Ph 2 | terminated | Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis |
| NCT04460326 In-FI results posted | H-39600 | Ph 3 | completed | Novolog vs. Fiasp Insulin in Non-critically Ill Hospitalized Patients With Type 2 Diabetes Mellitus |
| NCT04623086 GLIDING results posted | STUDY00008108 | Ph 4 | completed | Comparison of Glargine to Degludec Insulin Transition With or Without a Bridging Glargine Dose |
| NCT04153981 results posted | 17225 I4L-IN-ABEX | Ph 4 | completed | A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India |
| NCT04575181 | NN1965-4485 U1111-1243-0598, 2019-004381-18 | Ph 1 | completed | A Clinical Study to Compare the Efficacy and Safety of a Novel Medicine (NNC0268-0965) With Insulin Glargine |
| NCT05596747 | 18221 I8H-MC-BDDC | Ph 1 | completed | A Study of LY3209590 in Chinese Participants With Type 2 Diabetes Mellitus |
| NCT01524705 FLAT-SUGAR results posted | 42178 | Ph 4 | completed | FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR) |
| NCT05360537 | U Palermo | Ph 4 | completed | Effects of Degludec/Liraglutide on Time in Range, Inflammation and Endothelial Function vs Insulin Basal Bolus in Diabetic Inpatients |
| NCT03660553 results posted | 20180541 | Ph 4 | terminated | Simplified Insulin Regimen for the Elderly |
| NCT02408120 results posted | IRB00078695 | Ph 4 | completed | Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes |
| NCT03945656 | NN1436-4462 U1111-1214-2688, 2018-001993-74 | Ph 1 | completed | A Research Study of How Overdosing of a New Once Weekly Medicine NNC0148-0287 C (Insulin 287) Influences the Blood Sugar Level in People With Type 2 Diabetes |
| NCT04591626 AWARD-CHN3 results posted | 17731 H9X-MC-GBGO | Ph 3 | completed | A Study of Dulaglutide (LY2189265) in Chinese Participants With Type 2 Diabetes |
| NCT04605991 results posted | 17428 I8B-MC-ITSW | Ph 3 | completed | A Study of Mealtime Insulin LY900014 in Participants With Type 2 Diabetes Using Continuous Glucose Monitoring (PRONTO-Time in Range) |
| 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 |
| NCT04093752 results posted | 17210 I8F-MC-GPHO | Ph 3 | completed | A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes on Metformin With or Without Sulfonylurea (SURPASS-AP-Combo) |
| NCT04957914 | 16936 I8H-MC-BDCI, 2019-003537-42 | Ph 1 | completed | A Study of LY3209590 on Low Blood Sugar in Participants With Type 2 Diabetes Mellitus |
| NCT03668808 SafrTravlT1D results posted | ISS-001227 U1111-1210-7350 | Ph 4 | completed | Comparison of Insulin Degludec With Insulin Glargine U100 for Adults With Type 1 Diabetes Crossing Multiple Time Zones. |
| NCT04262661 | NN1147-4527 U1111-1232-3957, 2019-001927-11 | Ph 1 | completed | A Study to Look at How Safe NNC0472-0147 is in Healthy People and in People With Type 2 Diabetes |
| NCT05553093 | KY20220124-02 | Ph 4 | recruiting | Effects of Tirzepatide and Insulin Glargine on Glucolipid Metabolism and Brain Function in Patients With Type 2 Diabetes |
| NCT04136067 | NN1965-4457 U1111-1227-8683, 2019-000754-58 | Ph 1 | completed | A Study to Look at How Safe NNC0268-0965 is in People With Type 2 Diabetes |
| NCT01963728 results posted | Inova NODAT-001 | Ph 4 | terminated | Comparison of Insulin Therapy in Treating Post-Transplant Diabetes |
| NCT02545842 | LANTUL07190 U1111-1172-1058 | Ph 4 | completed | Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL) |
| NCT02855684 EDITION AP | EFC12814 U1111-1139-3894 | Ph 3 | completed | Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy |
| NCT02836704 | LANTUL07191 U1111-1172-2903 | Ph 4 | completed | Comparison of Standard vs Higher Starting Dose of Insulin Glargine in Chinese Patients With Type 2 Diabetes (Glargine Starting Dose) |
| NCT02623998 results posted | REMIT-Sita | Ph 3 | completed | Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita) |
| NCT03730662 SURPASS-4 results posted | 17072 I8F-MC-GPGM, 2018-002618-11 | Ph 3 | completed | A Study of Tirzepatide (LY3298176) Once a Week Versus Insulin Glargine Once a Day in Participants With Type 2 Diabetes and Increased Cardiovascular Risk |
| 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 |
| NCT03078478 CONCLUDE results posted | NN1250-4252 U1111-1184-8175, 2016-002801-20 | Ph 3 | completed | A Trial Comparing the Efficacy and Safety of Insulin Degludec and Insulin Glargine 300 Units/mL in Subjects With Type 2 Diabetes Mellitus Inadequately Treated With Basal Insulin With or Without Oral Antidiabetic Drugs |
Showing 50 of 191 trials
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Completed studies with published results, ranked by significance
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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.
Toujeo FDA Label Details
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- • Q4-2025: $367M
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.