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Related Concept Videos

Insulin Formulations: Types and Delivery01:27

Insulin Formulations: Types and Delivery

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Insulin preparations are categorized by their duration of action into short-acting and long-acting types. Two strategies are used to modify insulin's absorption and pharmacokinetic profile: slowing the absorption post-subcutaneous injection, or altering human insulin's amino acid sequence or protein structure. These changes retain the insulin's ability to bind to the insulin receptor, but alter its behavior in solution or after injection.
Short-acting insulins are divided into...
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Insulin: Biosynthesis, Chemistry, and Preparation01:25

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The endoplasmic reticulum (ER) of pancreatic β-cells synthesizes preproinsulin, which consists of a signal peptide, A and B chains, and a C-peptide. Preproinsulin is then cleaved and folded into proinsulin, which translocates to the Golgi apparatus for sorting and packaging into secretory granules. In these granules, enzymatic clipping generates insulin and C-peptide.
Damage or functional impairment of β-cells inhibits insulin production, leading to diabetes. Diabetes treatment...
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Insulin: Dosing Regimen and Adverse Effects01:16

Insulin: Dosing Regimen and Adverse Effects

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Insulin-replacement therapy usually includes both long-acting insulin (basal) and short-acting insulin (to cater to postprandial needs). In a diverse group of type 1 diabetes patients, the average daily insulin dose is typically 0.5-0.7 units/kg body weight. However, obese patients and pubertal adolescents may need more due to insulin resistance.
The basal dose constitutes about 40%-50% of the total daily dose, with the rest as premeal insulin. The mealtime insulin dose should mirror...
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Oral Hypoglycemic Agents: Glinides01:06

Oral Hypoglycemic Agents: Glinides

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Repaglinide (Prandin) and Nateglinide (Starlix), known as glinides, are oral insulin secretagogues that stimulate insulin release from pancreatic β cells by closing the ATP-sensitive potassium channels (KATP channel). Repaglinide controls insulin release from pancreatic β cells by managing potassium efflux. It shares two binding sites with sulfonylureas and also has a unique site, indicating overlapping mechanisms of action. With a rapid onset and a 4-7 hour duration, it effectively...
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Glucagon-like Receptor Agonists01:24

Glucagon-like Receptor Agonists

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Incretins include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion post-meals. In type 2 diabetes, GIP's efficacy is reduced, making GLP-1 a viable drug target. GIP originates from preproGIP.
GLP-1, when administered in high doses intravenously, triggers insulin secretion, inhibits glucagon release, slows gastric emptying, reduces food intake, and restores normal insulin secretion. However, its rapid inactivation by...
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Production of Pharmaceuticals01:30

Production of Pharmaceuticals

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Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under...
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U300, a novel long-acting insulin formulation.

Gemma Sutton1, Joan Minguet, Carmen Ferrero

  • 1Institute for Research and Medicine Advancement (IRMEDICA) , Barcelona , Spain.

Expert Opinion on Biological Therapy
|October 15, 2014
PubMed
Summary

Insulin glargine 300 U/ml (U300) offers a longer duration of action and less variable exposure than U100. This novel formulation demonstrates comparable efficacy and safety, with reduced body weight gain and fewer hypoglycemic events in diabetes patients.

Keywords:
U100U300diabetes mellitusglargineglycated hemoglobin A1Chypoglycaemiainsulin

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Area of Science:

  • Endocrinology
  • Pharmacology
  • Diabetes Mellitus Management

Background:

  • Insulin glargine 100 U/ml (U100) is a widely used long-acting basal insulin analog.
  • Ongoing research aims to optimize the pharmacokinetic and pharmacodynamic profiles of basal insulin therapies.
  • Insulin glargine 300 U/ml (U300) represents a novel, higher-concentration formulation.

Purpose of the Study:

  • To review the clinical efficacy and safety of insulin glargine U300.
  • To highlight recent data from the Phase III EDITION clinical trials.
  • To compare U300 with the established U100 formulation.

Main Methods:

  • Review of clinical data focusing on U300 in type 1 and type 2 diabetes.
  • Emphasis on findings from the EDITION Phase III clinical trials.
  • Pharmacokinetic and pharmacodynamic assessments of U300 versus U100.

Main Results:

  • Insulin glargine U300 exhibits a distinct pharmacokinetic and pharmacodynamic profile compared to U100.
  • U300 demonstrates a longer duration of action and reduced plasma insulin variability.
  • Similar efficacy and safety profiles were observed for both U100 and U300.

Conclusions:

  • Insulin glargine U300 offers improved metabolic control with a more predictable action profile.
  • U300 is associated with significant benefits, including less body weight gain.
  • A lower incidence of hypoglycemic events was noted with U300 compared to U100.