Data updated: May 26, 2026
SEMGLEE (insulin glargine)
Metabolic
Approved 2020-06-11
Semglee is a long-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 populations to manage blood sugar levels. It is not recommended for the treatment of diabetic ketoacidosis.
How SEMGLEE Works
This insulin analog functions by regulating glucose metabolism through several biological pathways. It lowers blood glucose by stimulating peripheral glucose uptake in skeletal muscle and fat while inhibiting the liver's production of glucose. Furthermore, it inhibits the processes of lipolysis and proteolysis and promotes protein synthesis.
2
Indications
--
Phase 3 Trials
5
Years on Market
Details
- Status
- Prescription
- First Approved
- 2020-06-11
- Patent Cliff
- 2022
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SEMGLEE Approval History
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 2020 to 2024
What SEMGLEE Treats
2 indicationsSEMGLEE is approved for 2 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diabetes
- Diabetic Ketoacidosis
Source: FDA Label
Pharmacists can substitute SEMGLEE for Basaglar without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
SEMGLEE Competitive Set
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What's emerging in SEMGLEE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications SEMGLEE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to SEMGLEE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
REZVOGLAR
INSULIN GLARGINE-AGLR
Eli Lilly
Shared indications:
DiabetesDiabetic Ketoacidosis
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Clinical Trial Registry
190 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 |
| 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 |
| NCT03951805 results posted | NN1436-4465 U1111-1219-5474, 2018-003406-11 | Ph 2 | completed | A Research Study to Compare Two Types of Insulin: Insulin 287 and Insulin Glargine in People With Type 2 Diabetes Who Have Not Used Insulin Before |
Showing 50 of 190 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.
SEMGLEE FDA Label Details
Indications & Usage
FDA Label (PDF)SEMGLEE is indicated for the treatment of Diabetes; Diabetic Ketoacidosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.