GLYBURIDE AND METFORMIN HYDROCHLORIDE (glyburide)
This combination medication helps adults with type 2 diabetes manage their blood sugar levels alongside diet and exercise. It pairs two different types of medicine, a sulfonylurea and a biguanide, to provide comprehensive glycemic control. Healthcare providers use this treatment to help patients maintain healthier glucose levels by addressing multiple aspects of how the body handles sugar.
How GLYBURIDE AND METFORMIN HYDROCHLORIDE Works
Glyburide works by binding to receptors in the pancreas to close potassium channels, which triggers the release of insulin. Metformin complements this by decreasing glucose production in the liver and absorption in the gut while helping the body's tissues use insulin more effectively. Together, these actions lower blood sugar levels both during fasting and after eating.
Details
- Status
- Discontinued
- First Approved
- 2004-02-18
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
GLYBURIDE AND METFORMIN HYDROCHLORIDE Approval History
What GLYBURIDE AND METFORMIN HYDROCHLORIDE Treats
1 indicationsGLYBURIDE AND METFORMIN HYDROCHLORIDE is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus
GLYBURIDE AND METFORMIN HYDROCHLORIDE Boxed Warning
LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria...
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1) ]. Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g. , acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided [see Dosage and Administration (2.3), Contraindications (4) and Warnings and Precautions (5.1) ]. If metformin-associated lactic acidosis is suspected, immediately discontinue glyburide and metformin hydrochloride and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1) ]. WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Post-marketing cases of metformin -associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms include malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. (5.1) Risk facto
GLYBURIDE AND METFORMIN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in GLYBURIDE AND METFORMIN HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GLYBURIDE AND METFORMIN HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to GLYBURIDE AND METFORMIN HYDROCHLORIDE
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Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01329016 GDM | 820 | Ph 1, Ph 2 | completed | Glyburide and Metformin for Gestational Diabetes Mellitus (GDM) |
| NCT01731431 INDAO | P110104 | Ph 3 | completed | Multicenter Randomized Trial of Non-inferiority Between Glyburide and Insulin for the Treatment of Gestational Diabetes |
| NCT03029702 MATCh-GDM results posted | PRO16100499 K23HD092893 | Ph 4 | completed | Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus |
| NCT01454154 | RPI 202 INTRuST-GLY | Ph 2 | completed | Glyburide (RP-1127) for Traumatic Brain Injury (TBI) |
| NCT02460874 results posted | IRB-16063003 | Ph 1, Ph 2 | terminated | Glyburide vs Placebo as Prophylaxis Against Cerebral Edema in Patients Receiving Radiosurgery for Brain Metastases (RAD 1502/UAB 1593) |
| NCT02524379 SCING results posted | 2014H0335 | Ph 1, Ph 2 | terminated | Spinal Cord Injury Neuroprotection With Glyburide |
| NCT00744965 results posted | 032011-086 042008-058 | Ph 4 | completed | Treatment of Mild Gestational Diabetes With Glyburide Versus Placebo |
| NCT03856970 | C3718-103 | Ph 1 | completed | Study to Evaluate the Effect of IW-3718 on the Pharmacokinetics of Oral Contraceptive, Levothyroxine, Glyburide, and Digoxin in Healthy Adult Volunteers |
| NCT03078725 GLAM | HSC-MS-16-1052 | Ph 4 | withdrawn | Failure Rate of GLyburide And Metformin Among Gestational Diabetics |
| NCT02815787 | QLHCPI-179 | Ph 1 | completed | The Drug -Drug Interaction of SP2086 and Glyburide |
| NCT01947699 | UPMC_GLY_GDM | Ph 4 | withdrawn | Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide |
| NCT00935363 | GlyburideOATP2C9 | Ph 1 | withdrawn | Interplay Between Organic Anion Transporting Polypeptide (OATP) Transporters Transporters and CYP2C9 in Glyburide Pharmacokinetics (PK) |
| NCT01716338 | A-15112.b | Ph 1 | completed | Glyburide Healthy Volunteer Study |
| NCT02183428 | 1218.30 | Ph 1 | completed | Bioavailability of BI 1356 and Glyburide in Healthy Male and Female Volunteers |
| NCT01456650 | INNSZ-ABCA1 | Ph 4 | completed | R230C and C230C Variants of ABCA1 and Glyburide Response |
| NCT01733108 | CR014872 28431754DIA1004 | Ph 1 | completed | A Study to Assess the Effects of Canagliflozin (JNJ-28431754) on the Pharmacokinetics, Pharmacodynamics, and Safety of Glyburide in Healthy Volunteers |
| NCT01029795 results posted | 13272 I2Q-MC-GMAJ | Ph 2 | terminated | A Study of LY2599506 (Oral Agent Medication: Glucokinase Activator 1) in Type 2 Diabetes Mellitus |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
GLYBURIDE AND METFORMIN HYDROCHLORIDE FDA Label Details
Indications & Usage
GLYBURIDE AND METFORMIN HYDROCHLORIDE is indicated for the treatment of Type 2 diabetes mellitus.
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metforminassociated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias,...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.