MedPath

Insulin Glulisine

Generic Name
Insulin Glulisine
Brand Names
Apidra
Drug Type
Biotech
CAS Number
207748-29-6
Unique Ingredient Identifier
7XIY785AZD
Background

Insulin glulisine is a short-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 among many other functions.

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 glulisine, 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 trying 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.

Marketed as the brand name product Apidra, insulin glulisine begins to exert its effects within 15 minutes of subcutaneous administration, while peak levels occur 30 to 90 minutes after administration. Due to its duration of action of around 5 hours, Apidra is considered "bolus insulin" as it provides high levels of insulin in a short period of time to mimic the release of endogenous insulin from the pancreas after meals. Bolus insulin is often combined with once daily, long-acting "basal insulin" such as Insulin detemir, Insulin degludec, and Insulin glargine to provide low concentrations of background insulin that can keep blood sugar stable between meals or overnight. 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 glulisine is a biosynthetic, rapid-acting human insulin analogue produced in a non-pathogenic laboratory strain of Escherichia coli (K12). This recombinant hormone differs from native human insulin in that the amino acid asparagine at position B3 is replaced by lysine and the lysine at position B29 is replaced by glutamic acid. These structural modifications decrease hexamer formation, stabilize insulin glulisine monomers and increase the rate of absorption and onset of action compared to human insulin.

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

用于治疗成人糖尿病。

Associated Conditions
Diabetes Mellitus, Type 1 Diabetes Mellitus, Hyperglycemia during critical illness

Better Acceptance of Single Injection Apidra Added to Once Daily Lantus Versus Twice Daily Premixed Insulin in Real Life Use Setting

Phase 4
Terminated
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Premixed insulin (Insulin Aspart 30/70 )
First Posted Date
2010-03-03
Last Posted Date
2013-05-29
Lead Sponsor
Sanofi
Target Recruit Count
52
Registration Number
NCT01079364
Locations
🇳🇱

Sanofi-Aventis Administrative Office, Gouda, Netherlands

Self Titration With Apidra to Reach Target Study (START)

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2009-11-13
Last Posted Date
2012-03-21
Lead Sponsor
Sanofi
Target Recruit Count
493
Registration Number
NCT01013571
Locations
🇨🇦

Sanofi-Aventis Administrative Office, Laval, Canada

A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone

First Posted Date
2009-09-18
Last Posted Date
2014-07-14
Lead Sponsor
Halozyme Therapeutics
Target Recruit Count
14
Registration Number
NCT00979875
Locations
🇺🇸

Profil Institute for Clinical Research, Inc., Chula Vista, California, United States

Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: INSULIN GLARGINE (HOE901)
First Posted Date
2009-08-25
Last Posted Date
2013-01-08
Lead Sponsor
Sanofi
Target Recruit Count
463
Registration Number
NCT00965549
Locations
🇬🇧

Investigational Site Number 826-130, Bristol, United Kingdom

🇬🇧

Investigational Site Number 826-149, Barnsley, United Kingdom

🇬🇧

Investigational Site Number 826-136, Bradford, United Kingdom

and more 71 locations

The Effect of Insulin Glulisine Compared With Insulin Aspart on Breakfast Post Prandial Glucose Levels in Prepubertal Children

Phase 4
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
First Posted Date
2009-06-04
Last Posted Date
2023-09-18
Lead Sponsor
Spectrum Health Hospitals
Target Recruit Count
16
Registration Number
NCT00913497
Locations
🇺🇸

Helen DeVos Childrens Hospital, Grand Rapids, Michigan, United States

Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 30 and Insulin Glargine and Insulin Glulisine Therapy in Subjects With Type 2 Diabetes

Phase 1
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
First Posted Date
2009-01-19
Last Posted Date
2017-01-06
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
24
Registration Number
NCT00824668
Locations
🇩🇪

Novo Nordisk Investigational Site, Neuss, Germany

Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 1
Interventions
First Posted Date
2008-02-05
Last Posted Date
2010-08-31
Lead Sponsor
Sanofi
Target Recruit Count
289
Registration Number
NCT00607087
Locations
🇬🇧

Sanofi-Aventis Administrative Office, Guildford Surrey, United Kingdom

Basal Bolus Insulin Versus SSRI in Type 2 Diabetes Undergoing General Surgery

Phase 4
Completed
Conditions
Inpatient Hyperglycemia
Type 2 Diabetes
Interventions
First Posted Date
2008-01-17
Last Posted Date
2014-03-12
Lead Sponsor
Emory University
Target Recruit Count
234
Registration Number
NCT00596687
Locations
🇺🇸

Grady Memorial Hospital, Atlanta, Georgia, United States

🇺🇸

Emory University Hospital, Atlanta, Georgia, United States

Effect of Insulin Glulisine vs Regular Human Insulin on Postprandial Endothelial Function in Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes Mellitus
Interventions
First Posted Date
2007-11-21
Last Posted Date
2007-11-21
Lead Sponsor
IKFE Institute for Clinical Research and Development
Target Recruit Count
15
Registration Number
NCT00562133
Locations
🇩🇪

Ikfe, Mainz, Rhineland-Palatinate, Germany

© Copyright 2025. All Rights Reserved by MedPath