DeepMed Research

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

Metformin Compared to Glyburide in Gestational Diabetes

Not Applicable

Completed

Conditions: Gestational Diabetes

Interventions: Drug: Glyburide
Drug: metformin

First Posted Date: 2009-08-26

Last Posted Date: 2024-11-19

Lead Sponsor: University of New Mexico

Target Recruit Count: 149

Registration Number: NCT00965991

Locations: 🇺🇸
University of New Mexico Diabetes in Pregnancy Clinic, Albuquerque, New Mexico, United States

Glycemic And Blood Pressure Control In Type 2 Diabetes, In A Primary Care Unit: A Staged Management Strategy

Conditions: Diabetes Mellitus
Arterial Hypertension

Interventions: Drug: Metformin
Drug: Glybenclamide
Drug: NPH insulin
Drug: Hydrochlorothiazide
Drug: Propranolol
Drug: Captopril
Drug: Amlodipine

First Posted Date: 2009-07-09

Last Posted Date: 2011-10-26

Lead Sponsor: Hospital de Clinicas de Porto Alegre

Target Recruit Count: 124

Registration Number: NCT00935805

Locations: 🇧🇷
Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil

Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK)

Phase 1

Withdrawn

Conditions: Healthy

Interventions: Drug: glyburide + fluconazole
Drug: glyburide + fluconazole + rifampin
Drug: glyburide + rifampin
Drug: glyburide

First Posted Date: 2009-07-09

Last Posted Date: 2015-01-14

Lead Sponsor: University of California, San Francisco

Registration Number: NCT00935363

A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Fasting Conditions

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg
Drug: CLUCOVANCE® 5 mg/500 mg Tablets, single dose

First Posted Date: 2009-03-19

Last Posted Date: 2010-08-17

Lead Sponsor: Actavis Inc.

Target Recruit Count: 36

Registration Number: NCT00865436

Locations: 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States

A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Fasting Conditions

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg
Drug: CLUCOVANCE® 5 mg/500 mg Tablets, single dose

First Posted Date: 2009-03-19

Last Posted Date: 2010-08-17

Lead Sponsor: Actavis Inc.

Target Recruit Count: 36

Registration Number: NCT00865241

Locations: 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States

A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Non-fasting Conditions

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg
Drug: CLUCOVANCE® 5 mg/500 mg Tablets, single dose

First Posted Date: 2009-03-19

Last Posted Date: 2010-08-17

Lead Sponsor: Actavis Inc.

Target Recruit Count: 24

Registration Number: NCT00864734

Locations: 🇺🇸
PRACS Institute, Ltd., Fargo, North Dakota, United States

Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fed

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Glucovance® 5 mg/500 mg Tablets
Drug: Glyburide/Metformin 5 mg/500 mg Tablets

First Posted Date: 2009-02-04

Last Posted Date: 2024-08-19

Lead Sponsor: Teva Pharmaceuticals USA

Target Recruit Count: 60

Registration Number: NCT00835991

Locations: 🇨🇦
Anapharm Inc., Sainte-Foy, Quebec, Canada

Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fasting

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Glyburide/Metformin 5 mg/500 mg Tablets
Drug: Glucovance® 5 mg/500 mg Tablets

First Posted Date: 2009-02-04

Last Posted Date: 2024-08-19

Lead Sponsor: Teva Pharmaceuticals USA

Target Recruit Count: 60

Registration Number: NCT00836472

Locations: 🇨🇦
Anapharm Inc., Sainte-Foy, Quebec, Canada

Efficacy and Safety of Pioglitazone in Treating Subjects With Vascular Complications Associated With Type 2 Diabetes Mellitus.

Phase 4

Completed

Conditions: Diabetes Mellitus

Interventions: Drug: Glibenclamide and Metformin
Drug: Pioglitazone and Metformin

First Posted Date: 2008-10-10

Last Posted Date: 2011-07-12

Lead Sponsor: Takeda

Target Recruit Count: 39

Registration Number: NCT00770835

Efficacy and Safety of TAK-559 Combined With Glyburide in Treating Subjects With Type 2 Diabetes Mellitus.

Phase 3

Terminated

Conditions: Diabetes Mellitus

Interventions: Drug: TAK-559 and glyburide
Drug: Glyburide

First Posted Date: 2008-09-25

Last Posted Date: 2012-02-02

Lead Sponsor: Takeda

Target Recruit Count: 447

Registration Number: NCT00759720

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