MedPath

Insulin Glulisine

Generic Name
Insulin Glulisine
Brand Names
Apidra
Drug Type
Biotech
Chemical Formula
-
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
Associated Therapies
-

Effect of LIXIsenatide on the Renal System

Phase 4
Completed
Conditions
Diabetic Nephropathy
Diabetic Kidney Disease
Diabetes Mellitus
Glucagon-Like Peptide 1
Interventions
First Posted Date
2014-10-28
Last Posted Date
2016-04-29
Lead Sponsor
Amsterdam UMC, location VUmc
Target Recruit Count
40
Registration Number
NCT02276196
Locations
🇳🇱

VU Universtiy Medical Center, Amsterdam, Netherlands

Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes

Phase 4
Terminated
Conditions
Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy
Interventions
First Posted Date
2014-01-29
Last Posted Date
2024-02-21
Lead Sponsor
Centre Hospitalier Universitaire Dijon
Target Recruit Count
14
Registration Number
NCT02048189
Locations
🇫🇷

CHU de Dijon, Dijon, France

🇫🇷

CHU de Besancon, Besancon, France

CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)

Phase 4
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
Drug: Commercial Hylenex® recombinant (hyaluronidase human injection)
Drug: Precommercial Hylenex recombinant (hyaluronidase human injection)
Drug: Insulin aspart
Drug: Insulin lispro
Drug: Insulin glulisine
First Posted Date
2013-05-08
Last Posted Date
2018-11-07
Lead Sponsor
Halozyme Therapeutics
Target Recruit Count
456
Registration Number
NCT01848990
Locations
🇺🇸

For additional information regarding investigative sites for this trial, call (858) 794-8889 8 AM to 5 PM Mon-Fri Pacific Standard Time, Madison, Wisconsin, United States

Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus

Phase 4
Completed
Conditions
Type 1 Diabetes Mellitus
Interventions
First Posted Date
2012-09-03
Last Posted Date
2014-10-07
Lead Sponsor
Medical University of Warsaw
Target Recruit Count
64
Registration Number
NCT01678235
Locations
🇵🇱

Department of Pediatrics, Medical University of Warsaw, Poland, Warsaw, Poland

Comparator Trial Using Insulin Glulisine vs. Insulin Lispro for Treatment of Gestational Diabetes

Phase 2
Completed
Conditions
Diabetes During Pregnancy
Interventions
First Posted Date
2012-08-13
Last Posted Date
2018-04-18
Lead Sponsor
Sansum Diabetes Research Institute
Target Recruit Count
17
Registration Number
NCT01662921
Locations
🇺🇸

William Sansum Diabetes Center, Santa Barbara, California, United States

Effect of Apidra Compared to Humalog in Decreasing Post-Prandial Hyperglycemia

Not Applicable
Completed
Conditions
Type 1 Diabetes
Interventions
First Posted Date
2012-06-18
Last Posted Date
2013-09-13
Lead Sponsor
University of Florida
Target Recruit Count
107
Registration Number
NCT01621776
Locations
🇺🇸

Camp Winona, DeLeon Springs, Florida, United States

Establishing Cardiovascular Biomarkers to Define Preferred Lantus® Use

Phase 4
Conditions
Insulin-requiring Type 2 Diabetes Mellitus
Interventions
First Posted Date
2011-12-29
Last Posted Date
2011-12-29
Lead Sponsor
ikfe-CRO GmbH
Target Recruit Count
60
Registration Number
NCT01500850
Locations
🇩🇪

ikfe GmbH, Mainz, Rheinland-Pfalz, Germany

Safety and Effectiveness Study of Intranasal Insulin Glulisine on Cognitive and Memory in Mild-Mod AD Patients.

Phase 2
Completed
Conditions
Alzheimer's Disease
Interventions
First Posted Date
2011-09-19
Last Posted Date
2015-10-19
Lead Sponsor
HealthPartners Institute
Target Recruit Count
12
Registration Number
NCT01436045
Locations
🇺🇸

HealthPartners Specialty Center - Center for Dementia & Alzheimer's Care, St. Paul, Minnesota, United States

Human Insulin Analogs: Evaluation of Inflammatory mRNA Expression of Macrophages and Endothelial Function of Short-acting Insulin - HERMES Pilot Study

Phase 4
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2011-08-16
Last Posted Date
2012-03-05
Lead Sponsor
ikfe-CRO GmbH
Target Recruit Count
12
Registration Number
NCT01417897
Locations
🇩🇪

ife GmbH, Clinic, Mainz, Rhineland-Palatinate, Germany

Comparison of Insulin Glargine/Insulin Glulisine Regimen to Insulin Aspart/Insulin Aspart Protamine 30/70 in Type 2 Diabetes Mellitus Patients (T2DM)

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-10-01
Last Posted Date
2013-07-08
Lead Sponsor
Sanofi
Target Recruit Count
161
Registration Number
NCT01212913
Locations
🇰🇷

Administrative Office, Seoul, Korea, Republic of

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