Glargine

ApprovedSmall molecule

Eli Lilly

Glargine is one of 99 small molecule programs targeting Diabetic Ketoacidosis. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Diabetic KetoacidosisActive, not recruiting

Type 2 Diabetes MellitusActive, not recruiting

HyperglycemiaTerminated

Diabetic NeuropathyActive, not recruiting

Diabetic KetoacidosisPreclinical

Active, not recruiting

Type 2 Diabetes MellitusPreclinical

Active, not recruiting

HyperglycemiaApproved

Terminated

Diabetic NeuropathyPreclinical

Active, not recruiting

Competition

Competitive Landscape

145 competitors in Type 2 Diabetes Mellitus

#DrugCompanyPhaseTrials

Glargine

Eli Lilly

Approved

3 2

Enavogliflozin

Daewoong Pharmaceutical Co. LTD.

Phase 3

1 3

Maridebart Cafraglutide

Amgen

Phase 3

3 4

HDM1002

HHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Phase 3

3 5

Retatrutide

Eli Lilly

Phase 3

1 6

Elecoglipron

AstraZeneca

Phase 3

5 7

Imeglimin

PPoxel SA

Phase 3

1 8

HM11260C

Hanmi Pharmaceutical Company Limited

Phase 3

3 9

Adenocard

Astellas

Preclinical

1 10

NOVOLIN R

Novo Nordisk

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Type 2 Diabetes8 trials

A Comparison Between Glargine and Detemir Insulin in Type 2 Diabetes

Completed·DDiabetes Care Center·N/A·NCT00457093·35 enrolled

Efficacy and Safety of Dapagliflozin for the Hospital Management of Patients With Type 2 Diabetes

Completed·MMedanta, The Medicity, India·Phase 4·NCT05457933·250 enrolled

Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes

Completed·EEmory University·Phase 4·NCT01845831·292 enrolled

Show 5 more trials

Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes

Completed·EEmory University·Phase 4·NCT02455076·150 enrolled

Study of Insulin Lispro in Participants With Inadequately Controlled Type 2 Diabetes

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT01215955·1,117 enrolled

Insulin Degludec and Glargine U100 for Management of Hospitalized and Discharged Patients With Type 2 Diabetes

Completed·EEmory University·Phase 4·NCT03336528·180 enrolled

Comparison of Glargine and Oral Antidiabetic Drugs (OADs) in Newly Diagnosed Type 2 Diabetes

Completed·—·N/A·NCT00978263·47 enrolled

Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin) Therapy in the Inpatients With Type 2 Diabetes

Completed·EEmory University·Phase 4·NCT01378117·90 enrolled

Type 1 Diabetes4 trials

Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.

Unknown status·—·Phase 4·NCT04664764·60 enrolled

Duration of The Honeymoon Phase of Type 1 Diabetes: A Comparison of Insulins Detemir, Glargine and NPH

Terminated·UUniversity of Texas Southwestern Medical Center·N/A·NCT00564018·33 enrolled

Early Glargine (Lantus) in DKA Management in Children With Type 1 Diabetes

Completed·UUniversity of Colorado, Denver·Phase 4·NCT03107208·61 enrolled

Show 1 more trial

Efficacy of Pramlintide on Prevention of Weight Gain Early Onset of Type 1 Diabetes

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT00505882

Type 2 Diabetes Mellitus3 trials

A Study in Patients With Type 2 Diabetes Mellitus

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01435616·1,538 enrolled

The Inova Type 2 Diabetes Mellitus Study

Withdrawn·IInova Health Care Services·N/A·NCT02222623

Study for Beinaglutide Versus Glargine Therapy in Glycemic Variability of Type 2 Diabetes Mellitus

Completed·XXijing Hospital·N/A·NCT03829891·60 enrolled

Diabetic Ketoacidosis3 trials

Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis

Unknown status·—·N/A·NCT05219942·52 enrolled

Use of Insulin Glargine to Treat Diabetic Ketoacidosis

Completed·VVanderbilt University Medical Center·N/A·NCT00179127·75 enrolled

Early Administration of Long-acting Insulin Treatment of Diabetic Ketoacidosis in Pediatric Type 1 Diabetes

Terminated·—·N/A·NCT02548494·17 enrolled

Medication2 trials

RISE Adult Medication Study

Completed·RRISE Study Group·Phase 3·NCT01779362·267 enrolled

RISE Pediatric Medication Study

Completed·RRISE Study Group·Phase 3·NCT01779375·91 enrolled

17 more indications

Diagnosis1 trial

Basal Analog Study - Comparison of Lantus or Levemir With NPH Insulin From T1DM Diagnosis

Unknown status·KKarolinska Institutet·Phase 4·NCT01271517·120 enrolled

Tics1 trial

Lispro Mix 25 vs. Glargine in Type 2 Diabetics

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00551356·53 enrolled

Effectiveness1 trial

Effectiveness of Adding Subcutaneous Long-acting Glargine to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

Completed·UUniversity of Colorado, Denver·Phase 1·NCT01153100·60 enrolled

Efficacy and Safety1 trial

Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM

Completed·—·N/A·NCT01855243·63 enrolled

SMA1 trial

24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00551538·15 enrolled

Diabetes Mellitus1 trial

A Study in Participants With Type I Diabetes Mellitus

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01454284·1,114 enrolled

Diabetic Neuropathy1 trial

Evaluation of Exenatide in Patients With Diabetic Neuropathy

Completed·UUniversity of Michigan·N/A·NCT00855439·46 enrolled

Type 1 Diabetes Mellitus1 trial

A Study in Participants With Type 1 Diabetes Mellitus

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT01481779·455 enrolled

Hyperglycemia1 trial

Use of NPH Versus Basal Bolus Insulin for Steroid Induced Hyperglycemia

Terminated·NNorthwestern University·Phase 4·NCT03511521·3 enrolled

Elderly1 trial

Simplified Insulin Protocol Using Lantus in Elderly

Completed·JJoslin Diabetes Center·Phase 4·NCT01480843·65 enrolled

Lip1 trial

SITAgliptin Plus GLARgine to Glycemic Control in the Hospital Setting (SITAGLAR-H)

Completed·—·Phase 4·NCT05579119·76 enrolled

Elderly Patients1 trial

Satisfaction of Treatment Among Elderly Patients With Insulin Therapy

Completed·EEmory University·Phase 4·NCT01240200·49 enrolled

Remission1 trial

Remission Through Early Monitored Insulin Therapy - Duration Month

Completed·SSandra Sobel·Phase 4·NCT03670641·10 enrolled

Adolescent1 trial

One Year Glargine Treatment in CFRD Children and Adolescents

Completed·FFederico II University·Phase 4·NCT00483769·20 enrolled

Endothelial Function1 trial

Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables

Completed·UUniversity of Palermo·Phase 4·NCT03824002·92 enrolled

T1DM1 trial

Comparative Glucose Clamp Study of Wockhardt's Recombinant Insulin Analog Glargine(Glaritus) With Lantus in T1DM

Completed·WWockhardt·Phase 1·NCT01357603·111 enrolled

Unspecified2 trials

Endothelial Effects of Basal Insulin: Detemir Versus Glargine

Completed·UUniversity of Padova·Phase 4·NCT00699686·50 enrolled

Effect of NPH Insulin, Insulin Detemir and Insulin Glargine on GH-IGF-IGFBP Axis

Completed·UUniversity of Aarhus·Phase 3·NCT01461616·19 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 17, 2000

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Jan 31, 2001

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Mar 7, 2001

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Aug 15, 2002

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

May 1, 2003

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Aug 10, 2004

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Feb 11, 2005

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Mar 15, 2005

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Apr 25, 2007

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Sep 9, 2009

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Mar 27, 2013

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

May 16, 2013

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Jun 5, 2013

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Jul 18, 2013

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Aug 14, 2013

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Oct 18, 2013

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Sep 5, 2014

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Feb 25, 2015

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Jun 16, 2015

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Jul 17, 2015

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Sep 29, 2015

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Feb 16, 2016

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Apr 13, 2016

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Jun 1, 2016

BASAGLAR

NDA BLA205692

Jun 17, 2016

BASAGLAR

NDA BLA205692

Jun 17, 2016

BASAGLAR

NDA BLA205692

Nov 21, 2016

SOLIQUA 100/33

NDA BLA208673

Nov 23, 2016

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Aug 29, 2017

SOLIQUA 100/33

NDA BLA208673

Sep 28, 2017

SOLIQUA 100/33

NDA BLA208673

Mar 26, 2018

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Sep 5, 2018

BASAGLAR

NDA BLA205692

Oct 25, 2018

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Oct 25, 2018

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Nov 29, 2018

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Feb 27, 2019

SOLIQUA 100/33

NDA BLA208673

May 9, 2019

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Nov 15, 2019

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Nov 15, 2019

BASAGLAR

NDA BLA205692

Nov 15, 2019

BASAGLAR

NDA BLA205692

Nov 15, 2019

SOLIQUA 100/33

NDA BLA208673

Nov 15, 2019

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Nov 15, 2019

SOLIQUA 100/33

NDA BLA208673

Nov 15, 2019

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Nov 15, 2019

BASAGLAR

NDA BLA205692

Nov 15, 2019

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Nov 26, 2019

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Jul 20, 2021

BASAGLAR

NDA BLA205692

Jul 28, 2021

SOLIQUA 100/33

NDA BLA208673

Jul 28, 2021

SEMGLEE

NDA BLA761201

Dec 17, 2021

REZVOGLAR

NDA BLA761215

Jun 7, 2022

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Jun 10, 2022

SOLIQUA 100/33

NDA BLA208673

Aug 16, 2022

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Nov 16, 2022

REZVOGLAR

NDA BLA761215

May 30, 2023

SEMGLEE

NDA BLA761201

Jun 29, 2023

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Jun 29, 2023

LANTUS SOLOSTAR, LANTUS

NDA BLA021081

Sep 28, 2023

SOLIQUA 100/33

NDA BLA208673

Nov 29, 2023

SEMGLEE

NDA BLA761201

Aug 9, 2024

REZVOGLAR

NDA BLA761215

Aug 29, 2024

TOUJEO SOLOSTAR, TOUJEO MAX SOLOSTAR

NDA BLA206538

Nov 1, 2024

SOLIQUA 100/33

NDA BLA208673

Nov 25, 2024

SEMGLEE

NDA BLA761201

May 28, 2025

SOLIQUA 100/33

NDA BLA208673

Mar 12, 2026

SOLIQUA 100/33

NDA BLA208673

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for Glargine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Glargine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Glargine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA208673). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Eli Lilly company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Eli Lilly

Glargine

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Type 2 Diabetes8 trials

Type 1 Diabetes4 trials

Type 2 Diabetes Mellitus3 trials

Diabetic Ketoacidosis3 trials

Medication2 trials

Diagnosis1 trial

Tics1 trial

Effectiveness1 trial

Efficacy and Safety1 trial

SMA1 trial

Diabetes Mellitus1 trial

Diabetic Neuropathy1 trial

Type 1 Diabetes Mellitus1 trial

Hyperglycemia1 trial

Elderly1 trial

Lip1 trial

Elderly Patients1 trial

Remission1 trial

Adolescent1 trial

Endothelial Function1 trial

T1DM1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News