GLIPIZIDE AND METFORMIN HYDROCHLORIDE (glipizide)
Glipizide and metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Details
- Status
- Prescription
- First Approved
- 2005-10-27
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
GLIPIZIDE AND METFORMIN HYDROCHLORIDE Approval History
What GLIPIZIDE AND METFORMIN HYDROCHLORIDE Treats
6 FDA approvalsOriginally approved for its first indication in 2005 . Covers 6 distinct patient populations.
- Other (6)
GLIPIZIDE 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 metformin-associated 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 ketonur...
WARNING: LACTIC ACIDOSIS Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated 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 PRECAUTIONS]. 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 PRECAUTIONS]. If metformin-associated lactic acidosis is suspected, immediately discontinue glipizide and metformin hydrochloride tablets and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see PRECAUTIONS].
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 AND METFORMIN HYDROCHLORIDE FDA Label Details
Indications & Usage
Glipizide and metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with 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 metformin-associated 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.