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Gliclazide

Generic Name
Gliclazide
Brand Names
Diamicron
Drug Type
Small Molecule
Chemical Formula
C15H21N3O3S
CAS Number
21187-98-4
Unique Ingredient Identifier
G4PX8C4HKV

Overview

Gliclazide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It has been classified differently according to its drug properties in which based on its chemical structure, gliclazide is considered a first-generation sulfonylurea due to the structural presence of a sulfonamide group able to release a proton and the presence of one aromatic group. On the other hand, based on the pharmacological efficacy, gliclazide is considered a second-generation sulfonylurea which presents a higher potency and a shorter half-life. Gliclazide belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating β cells of the pancreas to release insulin. Sulfonylureas increase both basal insulin secretion and meal-stimulated insulin release. Medications in this class differ in their dose, rate of absorption, duration of action, route of elimination and binding site on their target pancreatic β cell receptor. Sulfonylureas also increase peripheral glucose utilization, decrease hepatic gluconeogenesis and may increase the number and sensitivity of insulin receptors. Sulfonylureas are associated with weight gain, though less so than insulin. Due to their mechanism of action, sulfonylureas may cause hypoglycemia and require consistent food intake to decrease this risk. The risk of hypoglycemia is increased in elderly, debilitated and malnourished individuals. Gliclazide has been shown to decrease fasting plasma glucose, postprandial blood glucose and glycosolated hemoglobin (HbA1c) levels (reflective of the last 8-10 weeks of glucose control). Gliclazide is extensively metabolized by the liver; its metabolites are excreted in both urine (60-70%) and feces (10-20%).

Background

Gliclazide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM). It has been classified differently according to its drug properties in which based on its chemical structure, gliclazide is considered a first-generation sulfonylurea due to the structural presence of a sulfonamide group able to release a proton and the presence of one aromatic group. On the other hand, based on the pharmacological efficacy, gliclazide is considered a second-generation sulfonylurea which presents a higher potency and a shorter half-life. Gliclazide belongs to the sulfonylurea class of insulin secretagogues, which act by stimulating β cells of the pancreas to release insulin. Sulfonylureas increase both basal insulin secretion and meal-stimulated insulin release. Medications in this class differ in their dose, rate of absorption, duration of action, route of elimination and binding site on their target pancreatic β cell receptor. Sulfonylureas also increase peripheral glucose utilization, decrease hepatic gluconeogenesis and may increase the number and sensitivity of insulin receptors. Sulfonylureas are associated with weight gain, though less so than insulin. Due to their mechanism of action, sulfonylureas may cause hypoglycemia and require consistent food intake to decrease this risk. The risk of hypoglycemia is increased in elderly, debilitated and malnourished individuals. Gliclazide has been shown to decrease fasting plasma glucose, postprandial blood glucose and glycosolated hemoglobin (HbA1c) levels (reflective of the last 8-10 weeks of glucose control). Gliclazide is extensively metabolized by the liver; its metabolites are excreted in both urine (60-70%) and feces (10-20%).

Indication

For the treatment of NIDDM in conjunction with diet and exercise.

Associated Conditions

  • Type 2 Diabetes Mellitus

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2013/05/06
Phase 4
Completed
Royal Devon and Exeter NHS Foundation Trust
2013/01/01
Phase 4
Completed
2012/10/18
Phase 4
Completed
2012/09/06
Phase 4
Completed
2012/05/03
Phase 3
Completed
2011/08/22
Not Applicable
Completed
2009/12/01
Phase 4
Completed
2008/10/28
Phase 4
Completed
2008/08/20
Phase 4
Terminated
2008/08/18
Phase 4
Completed
Servier (Tianjin) Pharmaceutical Co. LTD.

FDA Drug Approvals

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Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

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Status
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HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Gliclazide Tablets
国药准字H13021831
化学药品
片剂
6/30/2020
Gliclazide Tablets
国药准字H44021592
化学药品
片剂
9/24/2019
Gliclazide Tablets
国药准字H14020012
化学药品
片剂
5/26/2022
Gliclazide Tablets
国药准字H14022297
化学药品
片剂
9/2/2020
Gliclazide Tablets
国药准字H19994060
化学药品
片剂
3/27/2020
Gliclazide Tablets
国药准字H41023569
化学药品
片剂
12/2/2019
Gliclazide Tablets
国药准字H11020121
化学药品
片剂
8/13/2020
Gliclazide Tablets
国药准字H37023013
化学药品
片剂
3/30/2020
Gliclazide Tablets
国药准字H37022311
化学药品
片剂
1/21/2020
Gliclazide Tablets
国药准字H20003361
化学药品
片剂
7/14/2020

PPB Drug Approvals

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