Glyburide

Generic Name: Glyburide

Brand Names: Diabeta, Glucovance, Glynase, Amglidia

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₈ClN_₃O_₅S

CAS Number: 10238-21-8

Unique Ingredient Identifier: SX6K58TVWC

Background: Glyburide is a second generation sulfonylurea used to treat patients with diabetes mellitus type II. It is typically given to patients who cannot be managed with the standard first line therapy, metformin. Glyburide stimulates insulin secretion through the closure of ATP-sensitive potassium channels on beta cells, raising intracellular potassium and calcium ion concentrations.

Glyburide was granted FDA approval on 1 May 1984. A formulation with metformin was granted FDA approval on on 31 July 2000.

Indication: Glyburide is indicated alone or as part of combination product with metformin, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus.

Associated Conditions: Gestational Diabetes Mellitus (GDM), Glycemic Control, Type 2 Diabetes Mellitus

Clinical Trials

Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Microgestin®
Drug: Levothyroxine
Drug: Glyburide
Drug: IW-3718
Drug: Digoxin

First Posted Date: 2019-02-27

Last Posted Date: 2019-07-29

Lead Sponsor: Ironwood Pharmaceuticals, Inc.

Target Recruit Count: 87

Registration Number: NCT03856970

Locations: 🇺🇸
PPD, Austin, Texas, United States

Glibenclamide Advantage in Treating Edema After Intracerebral Hemorrhage

Not Applicable

Completed

Conditions: Intracerebral Hemorrhage

Interventions: Drug: Glibenclamide Tablets
Other: Standard management for ICH

First Posted Date: 2018-11-15

Last Posted Date: 2022-04-08

Lead Sponsor: Xijing Hospital

Target Recruit Count: 220

Registration Number: NCT03741530

Locations: 🇨🇳
Ankang Central Hospital, Ankang, Shaanxi, China
🇨🇳
Hanzhong Central Hospital, Hanzhong, Shaanxi, China
🇨🇳
Xianyang Central Hospital, Xianyang, Shaanxi, China

and more 2 locations

Glibenclamide in Aneurysmatic Subarachnoid Hemorrhage

Phase 4

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Interventions: Other: Placebo
Drug: Glibenclamide

First Posted Date: 2018-06-26

Last Posted Date: 2018-06-26

Lead Sponsor: University of Sao Paulo General Hospital

Target Recruit Count: 50

Registration Number: NCT03569540

Locations: 🇧🇷
Hospital das Clínicas da Faculdade de Medicina de São Paulo, São Paulo, SP, Brazil

Safety and Efficacy of Glibenclamide Combined With Rt-PA in Acute Cerebral Embolism

Phase 2

Completed

Conditions: Acute Stroke

Interventions: Drug: Placebo
Drug: Glibenclamide

First Posted Date: 2017-09-15

Last Posted Date: 2023-06-12

Lead Sponsor: Nanfang Hospital, Southern Medical University

Target Recruit Count: 306

Registration Number: NCT03284463

Locations: 🇨🇳
Huadu District People's Hospital of Guangzhou, Guangzhou, Guangdong, China
🇨🇳
Maoming People's Hospital, Maoming, Guangdong, China
🇨🇳
Nanfang Hospital of Southern Medical University, Guangzhou, Guangdong, China

and more 5 locations

Effects of SGLT2 Inhibitor on Hemodynamic Parameters in Resistant Hypertensive Subjects

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2
Hypertension
Blood Pressure
Microalbuminuria
Obesity
Cardiac Hypertrophy
Vascular Stiffness

Interventions: Drug: Dapagliflozin 10mg
Drug: Glibenclamide 5Mg Tablet

First Posted Date: 2017-03-24

Last Posted Date: 2018-05-08

Lead Sponsor: University of Campinas, Brazil

Target Recruit Count: 16

Registration Number: NCT03089333

Locations: 🇧🇷
University of Campinas (UNICAMP), Campinas, São Paulo, Brazil

Failure Rate of GLyburide And Metformin Among Gestational Diabetics

Phase 4

Withdrawn

Conditions: Gestational Diabetes Mellitus, Class A2

Interventions: Drug: Glyburide
Drug: Metformin

First Posted Date: 2017-03-13

Last Posted Date: 2018-05-04

Lead Sponsor: The University of Texas Health Science Center, Houston

Registration Number: NCT03078725

Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

Phase 4

Completed

Conditions: Gestational Diabetes
Diabetes, Gestational
Pregnancy in Diabetes

Interventions: Drug: Insulin
Drug: Glyburide
Drug: Metformin

First Posted Date: 2017-01-24

Last Posted Date: 2024-11-28

Lead Sponsor: Maisa N. Feghali, MD

Target Recruit Count: 54

Registration Number: NCT03029702

Locations: 🇺🇸
Magee Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States

Assessment of Dapagliflozin Effect on Diabetic Endothelial Dysfunction of Brachial Artery

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2
Coronary Artery Disease
Carotid Artery Diseases

Interventions: Drug: Glibenclamide 5 mg
Drug: Dapagliflozin 10 mg

First Posted Date: 2016-09-29

Last Posted Date: 2023-03-10

Lead Sponsor: University of Campinas, Brazil

Target Recruit Count: 98

Registration Number: NCT02919345

Locations: 🇧🇷
State University of Campinas, Campinas, Sao Paulo, Brazil

Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema Following Large Hemispheric Infarction

Phase 3

Terminated

Conditions: Brain Edema
Stroke, Acute

Interventions: Drug: BIIB093
Drug: Placebo

First Posted Date: 2016-08-12

Last Posted Date: 2024-11-25

Lead Sponsor: Remedy Pharmaceuticals, Inc.

Target Recruit Count: 535

Registration Number: NCT02864953

Locations: 🇺🇸
Maine Medical Center, Portland, Maine, United States
🇺🇸
Lyerly Neurosurgery Baptist Health, Jacksonville, Florida, United States
🇺🇸
University of Maryland, Baltimore, Maryland, United States

and more 246 locations

Low dosE GlibENclamide in Diabetes Part A

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Glibenclamide

First Posted Date: 2016-07-12

Last Posted Date: 2017-05-31

Lead Sponsor: University of Oxford

Target Recruit Count: 16

Registration Number: NCT02830048

Locations: 🇬🇧
Clinical Research Unit, OCDEM, Churchill Hospital, Oxford, Oxfordshire, United Kingdom

Drug Development Updates

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