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%).
Indication
For the treatment of NIDDM in conjunction with diet and exercise.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/01/24 | Not Applicable | Not yet recruiting | Yan Bi | ||
2024/01/23 | Not Applicable | Recruiting | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2023/10/17 | Not Applicable | Completed | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2019/12/13 | Phase 1 | Completed | |||
2018/10/15 | Not Applicable | Completed | |||
2018/03/16 | Phase 1 | Completed | |||
2018/02/14 | Phase 4 | UNKNOWN | M.H.H. Kramer | ||
2017/10/18 | Phase 3 | UNKNOWN | Sherief Abd-Elsalam | ||
2017/03/01 | Phase 4 | Completed | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | ||
2016/12/02 | Phase 1 | Withdrawn | Disphar International B.V. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
No FDA approvals found for this drug. |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
DIAPRO TABLET 80 mg | SIN13085P | TABLET | 80 mg | 4/12/2005 | |
DIANORM TABLET 80 mg | SIN10123P | TABLET | 80 mg | 10/2/1998 | |
DIAMICRON MR TABLET 60mg | SIN13868P | TABLET, FILM COATED, EXTENDED RELEASE | 60mg | 9/22/2010 | |
DIAMICRON TABLET 80 mg | SIN04316P | TABLET | 80 mg | 4/20/1990 | |
DIAMICRON MR TABLET 30 mg | SIN11761P | TABLET | 30 mg | 1/10/2002 | |
GLIAVIS MR TABLET 30MG | SIN15478P | TABLET, EXTENDED RELEASE | 30 mg | 5/8/2018 | |
GLIMICRON TABLET 80 mg | SIN09302P | TABLET | 80.00 mg | 4/16/1997 | |
MELICRON TABLET 80 mg | SIN11662P | TABLET, FILM COATED | 80 mg | 9/6/2001 | |
APO-GLICLAZIDE TABLET 80MG | SIN13468P | TABLET | 80 mg | 5/15/2008 | |
SUN-GLIZIDE TABLET 80 mg | SIN09350P | TABLET | 80 mg | 5/20/1997 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
DIAMICRON MR TAB 60MG | N/A | servier hong kong limited | N/A | N/A | 8/25/2011 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Glyade 80 mg tablet | 17649 | Medicine | A | 9/20/1991 | |
APX-GLICLAZIDE gliclazide 80 mg tablet blister pack | 337479 | Medicine | A | 6/23/2020 | |
ARDIX GLICLAZIDE 60 mg MR gliclazide 60 mg tablet blister pack | 154049 | Medicine | A | 11/11/2009 | |
PHARMACOR GLICLAZIDE gliclazide 30 mg modified release tablet blister pack | 316934 | Medicine | A | 4/29/2020 | |
GLICLAZIDE-STR gliclazide 80 mg tablet blister pack | 337483 | Medicine | A | 6/23/2020 | |
NIDEM gliclazide 80 mg tablet blister pack | 79023 | Medicine | A | 8/17/2001 | |
Gliclazide tablet 80 mg (blister) | 201996 | Medicine | A | 10/18/2012 | |
PHARMACOR GLICLAZIDE MR gliclazide 60 mg modified release tablet blister pack | 316923 | Medicine | A | 4/29/2020 | |
GLICLAZIDE MR-WGR 30mg tablets blister pack | 151305 | Medicine | A | 5/20/2009 | |
GLICLAZIDE MR VIATRIS gliclazide 30 mg modified release tablet blister pack | 295541 | Medicine | A | 3/31/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
GLICLAZIDE -TAB 80MG | proval pharma division of servier canada inc | 02155850 | Tablet - Oral | 80 MG | 8/13/1997 |
GLICLAZIDE | sanis health inc | 02287072 | Tablet - Oral | 80 MG | 2/25/2010 |
DIAMICRON MR | servier canada inc | 02356422 | Tablet (Extended-Release) - Oral | 60 MG | 12/9/2010 |
APO-GLICLAZIDE | 02245247 | Tablet - Oral | 80 MG | 7/2/2002 | |
SANDOZ GLICLAZIDE | 02254719 | Tablet - Oral | 80 MG | 8/9/2004 | |
APO-GLICLAZIDE MR | 02407124 | Tablet (Extended-Release) - Oral | 60 MG | 4/14/2015 | |
GLICLAZIDE MR | sanis health inc | 02524856 | Tablet (Extended-Release) - Oral | 30 MG | 7/8/2022 |
GLIC | prempharm inc | 02248210 | Tablet - Oral | 80 MG | 10/2/2003 |
MINT-GLICLAZIDE MR | mint pharmaceuticals inc | 02423286 | Tablet (Extended-Release) - Oral | 30 MG | 6/2/2014 |
GLICLAZIDE-80 | PRO DOC LIMITEE | 02248453 | Tablet - Oral | 80 MG | 12/10/2003 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
GLICLAZIDA CINFA 30 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | Laboratorios Cinfa S.A. | 78439 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
GULRIKE 60 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | Krka D.D. Novo Mesto | 77494 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
GLICLAZIDA AUROVITAS 60 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | Aurovitas Spain, S.A.U. | 88794 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
DIAMICRON 30 mg COMPRIMIDOS DE LIBERACION MODIFICADA | 63644 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
GLICLAZIDA COMBIX 30 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | Laboratorios Combix S.L.U. | 82907 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
SODOR 30 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | Uxa Farma S.A. | 84501 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
GLICLAZIDA KRKA 60 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | Krka D.D. Novo Mesto | 77493 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
DIAMICRON 60 mg COMPRIMIDOS DE LIBERACION MODIFICADA | 71738 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
GLICLAZIDA RATIOPHARM 60 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | Teva Pharma S.L.U. | 81122 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
GLICLAZIDA SANDOZ 30 MG COMPRIMIDOS DE LIBERACION MODIFICADA EFG | Sandoz Farmaceutica S.A. | 79929 | COMPRIMIDO DE LIBERACIÓN MODIFICADA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.