MedPath

Insulin glargine

Generic Name
Insulin glargine
Brand Names
Basaglar, Lantus, Rezvoglar, Semglee, Soliqua, Toujeo, Toujeo (previously Optisulin), Abasaglar (previously Abasria)
Drug Type
Biotech
Chemical Formula
-
CAS Number
160337-95-1
Unique Ingredient Identifier
2ZM8CX04RZ
Background

Insulin glargine is a long-acting form of insulin used for the treatment of hyperglycemia caused by Type 1 and Type 2 Diabetes. Insulin is typically prescribed for the management of diabetes mellitus to mimic the activity of endogenously produced human insulin, a peptide hormone produced by beta cells of the pancreas that promotes glucose metabolism. Insulin is released from the pancreas following a meal to promote the uptake of glucose from the blood into internal organs and tissues such as the liver, fat cells, and skeletal muscle. Absorption of glucose into cells allows for its transformation into glycogen or fat for storage. Insulin also inhibits hepatic glucose production, enhances protein synthesis, and inhibits lipolysis and proteolysis.

Insulin is an important treatment in the management of Type 1 Diabetes (T1D), which is caused by an autoimmune reaction that destroys the beta cells of the pancreas, resulting in the body not being able to produce or synthesize the insulin needed to manage circulating blood sugar levels. As a result, people with T1D rely primarily on exogenous forms of insulin, such as insulin glargine, to lower glucose levels in the blood. Insulin is also used in the treatment of Type 2 Diabetes (T2D), another form of diabetes mellitus that is a slowly progressing metabolic disorder caused by a combination of genetic and lifestyle factors that promote chronically elevated blood sugar levels. Without treatment or improvement in non-pharmacological measures such as diet and exercise to lower blood glucose, high blood sugar eventually causes cellular resistance to endogenous insulin, and in the long term, damage to pancreatic islet cells. Insulin is typically prescribed later in the course of T2D, after several oral medications such as Metformin, Gliclazide, or Sitagliptin have been tried, when sufficient damage has been caused to pancreatic cells that the body is no longer able to produce insulin on its own.

Available as the brand name product Lantus, insulin glargine has a duration of action up to 24 hours allowing for once-daily dosing, typically at bedtime. Due to its duration of action, Lantus is considered "basal insulin" as it provides low concentrations of background insulin that can keep blood sugar stable between meals or overnight. Basal insulin is often combined with short-acting "bolus insulin" such as Insulin lispro, Insulin glulisine, and Insulin aspart to provide higher doses of insulin that are required following meals. Use of basal and bolus insulin together is intended to mimic the pancreas' production of endogenous insulin, with a goal of avoiding any periods of hypoglycemia.

Insulin glargine is also available as the biosimilar, or "follow-on" product, Basaglar in the US and as Abasaglar in the EU. As of 2015, insulin glargine was reformulated by Sanofi as the product Toujeo in an extra-concentrated form containing 300IU/mL (compared to 100IU/mL contained in Lantus). Use of the higher concentrated Toujeo as compared to Lantus results in slightly different pharmacokinetics, with a later onset (up to 6 hours) and duration of action (up to 30 hours). In 2021, another biosimilar, Semglee (insulin glargine-yfgn), became the first interchangeable (with Lantus) biosimilar insulin to receive FDA approval.

Insulin glargine is produced by recombinant DNA technology using a non-pathogenic laboratory strain of Escherichia coli (K12) as the production organism. Insulin glargine differs from endogenous human insulin by the replacement of an asparagine residue at position A21 of the A-chain with glycine and addition of two arginines to the C-terminus (positions B31 and 32) of the B-chain. The resulting protein is soluble at pH 4 and forms microprecipitates at physiological pH 7.4 allowing for the slow release of small amounts of insulin glargine, giving the drug a long duration of action and no pronounced peak concentration.

Without an adequate supply of insulin to promote absorption of glucose from the bloodstream, blood sugar levels can climb to dangerously high levels and can result in symptoms such as fatigue, headache, blurred vision, and increased thirst. If left untreated, the body starts to break down fat, instead of glucose, for energy which results in a build-up of ketone acids in the blood and a syndrome called ketoacidosis, which is a life-threatening medical emergency. In the long term, elevated blood sugar levels increase the risk of heart attack, stroke, and diabetic neuropathy.

Indication

Insulin glargine is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.

Associated Conditions
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Associated Therapies
-

Efficacy and Safety of SHR-3167 and Insulin Glargine in Type 2 Diabetes Subjects

Phase 2
Not yet recruiting
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2024-11-14
Last Posted Date
2024-11-14
Lead Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Target Recruit Count
273
Registration Number
NCT06688123
Locations
🇨🇳

Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, China

🇨🇳

Shanghai Sixth People's Hospital, Shanghai, Shanghai, China

RCT Glargine vs NPH for Treatment of DM in Pregnancy

Phase 3
Recruiting
Conditions
Diabetes Mellitus in Pregnancy
Type 2 Diabetes Mellitus (T2DM)
Gestational Diabetes Mellitus, Class A2
Interventions
Drug: insulin NPH
Drug: Insulin glargine
First Posted Date
2024-09-30
Last Posted Date
2024-09-30
Lead Sponsor
Loyola University
Target Recruit Count
160
Registration Number
NCT06619301
Locations
🇺🇸

Loyola University Medical Center, Maywood, Illinois, United States

A Study of LY900014 in Adult Participants With Type 2 Diabetes Mellitus in India

Phase 4
Recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2024-04-17
Last Posted Date
2025-01-03
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
112
Registration Number
NCT06370715
Locations
🇮🇳

Osmania Medical College & Hospital, Hyderabad, Andhra Pradesh, India

🇮🇳

King George Hospital, Visakhapatnam, Visakhapatnam, Andhra Pradesh, India

🇮🇳

Diabetes Research Centre, Royapuram, Chennai India, India

and more 9 locations

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

Phase 3
Active, not recruiting
Conditions
Diabetes, Type 2
Interventions
First Posted Date
2024-04-02
Last Posted Date
2025-01-07
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
404
Registration Number
NCT06340854
Locations
🇺🇸

Advanced Investigative Medicine, Inc., Hawthorne, California, United States

🇺🇸

Scripps Whittier Diabetes Inst, La Jolla, California, United States

🇺🇸

Clinical Trials Research, Lincoln, California, United States

and more 67 locations

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)

Phase 3
Active, not recruiting
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2024-02-21
Last Posted Date
2024-11-19
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
474
Registration Number
NCT06269107
Locations
🇺🇸

Consano Clinical Research, LLC, Shavano Park, Texas, United States

🇺🇸

TPMG Clinical Research, Newport News, Virginia, United States

🇨🇳

Peking University People's Hospital, Beijing, Beijing, China

and more 89 locations

Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia

Not Applicable
Completed
Conditions
Critical Illness
Glycemic Control
Insulin
Interventions
First Posted Date
2023-12-21
Last Posted Date
2024-08-05
Lead Sponsor
Ain Shams University
Target Recruit Count
90
Registration Number
NCT06178874
Locations
🇪🇬

Ain shams university, Cairo, Egypt

The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes

Phase 4
Recruiting
Conditions
Insulin Pump,Continuous Glucose Monitoring Technology
Interventions
First Posted Date
2023-11-13
Last Posted Date
2023-11-13
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
210
Registration Number
NCT06127433
Locations
🇨🇳

刘烈华, Guandong, China

Early Administration of Insulin Glargine in Patients With Diabetic Ketoacidosis

Phase 2
Terminated
Conditions
DKA
Interventions
First Posted Date
2023-08-23
Last Posted Date
2024-06-18
Lead Sponsor
HealthPartners Institute
Target Recruit Count
8
Registration Number
NCT06007508
Locations
🇺🇸

Regions Hospital, Saint Paul, Minnesota, United States

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

Phase 3
Active, not recruiting
Conditions
Type 2 Diabetes
Obesity
Overweight or Obesity
Overweight
Cardiovascular Diseases
Chronic Kidney Disease
Interventions
Drug: Orforglipron
Drug: Insulin Glargine
First Posted Date
2023-04-07
Last Posted Date
2024-12-10
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
2749
Registration Number
NCT05803421
Locations
🇺🇸

The Research Center of The Upstate, Greenville, South Carolina, United States

🇺🇸

Care Access - Mauldin, Mauldin, South Carolina, United States

🇺🇸

New Phase Research and Development, Knoxville, Tennessee, United States

and more 373 locations

Remote And Decentralised Innovative Approaches to Clinical Trials (RADIAL)

Phase 4
Active, not recruiting
Conditions
Diabetes Mellitus, Type 2
Interventions
Other: Methodological intervention
Drug: Toujeo
First Posted Date
2023-03-22
Last Posted Date
2024-06-12
Lead Sponsor
Mira Zuidgeest
Target Recruit Count
107
Registration Number
NCT05780151
Locations
🇩🇪

Studienzentrum Diabetespraxis Dr. Braun, Berlin, Germany

🇬🇧

FutureMeds Soho Health Centre, Birmingham, United Kingdom

🇩🇪

Klinische Forschung Dresden GmbH, Dresden, Germany

and more 6 locations
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