MedPath

Gliclazide

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

Effect of Dapagliflozin on Vascular Functions in Patients With Type 2 Diabetes Compared to Gliclazide

Phase 4
Completed
Conditions
Diabetes
Interventions
First Posted Date
2015-11-20
Last Posted Date
2018-09-11
Lead Sponsor
Seoul National University Bundang Hospital
Target Recruit Count
32
Registration Number
NCT02610088
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam, Gyeonggi, Korea, Republic of

Sulphonylurea Receptor Mutation and Responsiveness to Gliclazide - a Pilot Proof of Concept, Randomised Cross-over Study

Phase 4
Completed
Conditions
Diabetes
Interventions
First Posted Date
2014-07-28
Last Posted Date
2016-09-01
Lead Sponsor
Khoo Teck Puat Hospital
Target Recruit Count
8
Registration Number
NCT02201602
Locations
🇸🇬

Khoo Teck Puat Hospital, Singapore, Singapore

Safety Evaluation of Adverse Reactions in Diabetes

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2014-03-20
Last Posted Date
2018-02-07
Lead Sponsor
Charles University, Czech Republic
Target Recruit Count
42
Registration Number
NCT02092597
Locations
🇨🇿

General University Hospital, Prague, Czechia

Dipeptidyl Peptidase-4 Inhibition in Psoriasis Patients With Diabetes (DIP): A Randomized Clinical Trial.

Phase 2
Completed
Conditions
Psoriasis
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2013-11-25
Last Posted Date
2020-05-14
Lead Sponsor
University College Dublin
Target Recruit Count
20
Registration Number
NCT01991197
Locations
🇮🇪

UCD Clinical Research Centre, St Vincent's University Hospital,, Dublin 4, Ireland

🇮🇪

The Adelaide and Meath Hospital, Dublin 24, Ireland

Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan

First Posted Date
2013-01-01
Last Posted Date
2013-10-17
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
557
Registration Number
NCT01758380
Locations
🇬🇧

Novartis Investigative Site, Manchester, United Kingdom

A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2012-05-03
Last Posted Date
2018-08-17
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
498
Registration Number
NCT01590771

Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment

Phase 4
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2009-12-01
Last Posted Date
2014-07-09
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
440
Registration Number
NCT01022762

Variation in Sulphonylurea Response in Type 2 Diabetes

Phase 4
Terminated
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-08-20
Last Posted Date
2018-05-03
Lead Sponsor
NHS Tayside
Target Recruit Count
14
Registration Number
NCT00738088
Locations
🇬🇧

NHS Tayside, Dundee, United Kingdom

Peripheral and Coronary Endothelial Dysfunction In Type 2diabetic Patients- Role of Metformin

Phase 3
Terminated
Conditions
Coronary and Peripheral Endothelial Dysfunction
First Posted Date
2005-09-15
Last Posted Date
2007-10-05
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
30
Registration Number
NCT00169624
Locations
🇫🇷

Laurent SEBBAG, Lyon, France

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