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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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
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No EMA approvals found for this drug. |
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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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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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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No PPB approvals found for this drug. |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
AKM GLICLAZIDE gliclazide 30 mg modified release tablet bottle pack | 316927 | Medicine | A | 4/29/2020 | |
APX-GLICLAZIDE gliclazide 80 mg tablet bottle | 337477 | Medicine | A | 6/23/2020 | |
GLICLAZIDE GH MR gliclazide 60 mg modified release tablet blister pack | 370852 | Medicine | A | 11/14/2022 | |
DIAMICRON 60 mg MR gliclazide 60 mg tablet blister pack | 154042 | Medicine | A | 11/11/2009 | |
Gliclazide 80mg tablet | 17650 | Medicine | A | 9/20/1991 | |
GLICLAZIDE-WGR gliclazide 80 mg tablet bottle | 337480 | Medicine | A | 6/23/2020 | |
AKM GLICLAZIDE gliclazide 30 mg modified release tablet blister pack | 316926 | Medicine | A | 4/29/2020 | |
GLICLAZIDE SANDOZ MR gliclazide 60 mg modified release tablet blister pack | 366610 | Medicine | A | 6/17/2022 | |
GLYADE MR gliclazide 30mg tablet blister pack | 139728 | Medicine | A | 9/7/2007 | |
DIDAX 60mg MR gliclazide 60 mg modified release tablet blister pack | 233158 | Medicine | A | 12/2/2015 |