GLIPIZIDE
Glipizide is a sulfonylurea indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Its efficacy is dependent upon functioning pancreatic beta cells. While effective for many patients, some may exhibit an initial lack of response (primary failure) or a gradual loss of effectiveness over time (secondary failure).
How GLIPIZIDE Works
Glipizide lowers blood glucose by stimulating the release of insulin from pancreatic beta cells. In humans, it acutely enhances the insulinotropic response to a meal, typically within 30 minutes of oral administration. While fasting insulin levels remain largely unaffected during long-term use, the postprandial insulin response continues to be enhanced. The mechanism of action during chronic administration is not fully established but may involve extrapancreatic effects. Despite a short plasma half-life, glucose control can persist for up to 24 hours in some patients.
Details
- Status
- Discontinued
- First Approved
- 1994-05-10
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET
Companies
GLIPIZIDE Approval History
What GLIPIZIDE Treats
1 indicationsGLIPIZIDE is approved for 1 conditions since its original approval in 1994. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Type 2 diabetes mellitus
GLIPIZIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 GLIPIZIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GLIPIZIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to GLIPIZIDE
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01762046 SUGAR-MGH results posted | 2007p000193 | Ph 1 | completed | Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans |
| NCT06168812 | 23-318 | Ph 2 | active not recruiting | A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic Cancer |
| NCT01698775 results posted | 3102-019 2012-002332-85 | Ph 3 | completed | A Study of Omarigliptin (MK-3102) in Participants With Type 2 Diabetes Mellitus With Chronic Kidney Disease or Kidney Failure on Dialysis (MK-3102-019) |
| NCT00885352 results posted | 0431-128 2009_577 | Ph 3 | completed | Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128) |
| NCT01951651 results posted | H-26030 | Ph 4 | completed | Effect of Exenatide on Liver and Heart Fat and Inflammation |
| NCT00660907 results posted | D1690C00004 | Ph 3 | completed | Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients |
| NCT00856284 ENDURE results posted | SYR-322_305 2008-007444-34, U1111-1111-7397 | Ph 3 | completed | Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Patients With Type 2 Diabetes Mellitus |
| NCT00707993 results posted | SYR-322_303 2008-000959-10, U1111-1112-7905 | Ph 3 | completed | Efficacy and Safety of Alogliptin Compared to Glipizide in Elderly Diabetics |
| NCT01020123 results posted | D1020C00009 | Ph 2 | completed | Evaluate Efficacy, Safety and Tolerability of AZD1656 as Add-on Treatment to Metformin in Type 2 Diabetes Mellitus (TD2M) Patients |
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.
GLIPIZIDE FDA Label Details
Indications & Usage
GLIPIZIDE is indicated for the treatment of Type 2 diabetes mellitus.
Looking for the branded version?
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Full clinical data, patents, trials, and competitive landscape for glipizide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.