Overview
Glipizide is an oral hypoglycemic agent in the second-generation sulfonylurea drug class that is used to control blood sugar levels in patients with type 2 diabetes mellitus. It was first introduced in 1984 and is available in various countries including Canada and the U.S. According to the 2018 Clinical Practice Guidelines by Diabetes Canada, sulfonylurea drugs are considered a second-line glucose-lowering therapy following metformin. Because sulfonylureas require functional pancreatic beta cells for their therapeutic effectiveness, sulfonylureas are more commonly used for early-stage type 2 diabetes when there is no progressed pancreatic failure. Compared to the first-generation sulfonylureas, such as tolbutamide and chlorpropamide, second-generation sulfonylureas contain a more non-polar side chain in their chemical structure, which enhances their hypoglycemic potency. Compared to other members of the sulfonylurea drug group, glipizide displays rapid absorption and onset of action with the shortest half-life and duration of action, reducing the risk for long-lasting hypoglycemia that is often observed with blood glucose-lowering agents. Glipizide was first approved by the FDA in 1994 and is available in extended-release tablets under the brand name Glucotrol®, as well as in combination with metformin under the brand name Metaglip®.
Indication
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/12/13 | Phase 2 | Recruiting | |||
2021/12/16 | Phase 1 | Recruiting | |||
2021/10/11 | N/A | Recruiting | |||
2016/09/22 | Phase 4 | Completed | |||
2015/11/18 | Not Applicable | Completed | |||
2013/09/26 | Phase 4 | Completed | |||
2013/01/07 | Phase 1 | Active, not recruiting | |||
2013/01/01 | Phase 4 | UNKNOWN | Shanghai Jiao Tong University School of Medicine | ||
2012/10/03 | Phase 3 | Completed | |||
2010/12/28 | Phase 4 | Completed | Cook County Health |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Direct_Rx | 61919-715 | ORAL | 10 mg in 1 1 | 8/19/2019 | |
NuCare Pharmaceuticals,Inc. | 68071-4223 | ORAL | 5 mg in 1 1 | 8/23/2022 | |
Aphena Pharma Solutions - Tennessee, LLC | 71610-393 | ORAL | 10 mg in 1 1 | 7/6/2020 | |
Aidarex Pharmaceuticals LLC | 33261-433 | ORAL | 10 mg in 1 1 | 1/3/2014 | |
Bryant Ranch Prepack | 72162-2215 | ORAL | 10 mg in 1 1 | 1/5/2024 | |
Roerig | 0049-0174 | ORAL | 5 mg in 1 1 | 8/28/2023 | |
REMEDYREPACK INC. | 70518-3688 | ORAL | 5 mg in 1 1 | 3/27/2024 | |
Golden State Medical Supply, Inc. | 51407-621 | ORAL | 10 mg in 1 1 | 3/20/2023 | |
Northwind Pharmaceuticals | 51655-982 | ORAL | 10 mg in 1 1 | 1/1/2023 | |
Rising Pharmaceuticals, Inc. | 64980-281 | ORAL | 10 mg in 1 1 | 10/17/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
SUNGLUCON TABLET 5 mg | SIN10724P | TABLET | 5 mg | 1/29/1999 | |
DIACTIN TABLET 5 MG | SIN13084P | TABLET | 5 MG | 4/12/2005 | |
DIBIZIDE TABLETS 5 mg | SIN10183P | TABLET | 5 mg | 10/6/1998 | |
MINIDIAB TABLET 5 mg | SIN04059P | TABLET | 5 mg | 3/28/1990 | |
GLYNASE TABLET 5 mg | SIN08508P | TABLET | 5 mg | 1/5/1996 | |
DIACON TABLET 5 mg | SIN12348P | TABLET | 5 mg | 7/18/2003 | |
GLIPIZIDE TABLET 5 mg | SIN10237P | TABLET | 5 mg | 10/10/1998 | |
BEAPIZIDE TABLETS 5mg | SIN10440P | TABLET | 5 mg | 11/16/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Glipizide Extended Release Tablets | 国药准字HJ20160140 | 化学药品 | 片剂 | 10/14/2024 | |
Glipizide Extended Release Tablets | 国药准字HJ20150361 | 化学药品 | 片剂 | 10/14/2024 | |
Glipizide Extended Release Tablets | 国药准字HJ20160139 | 化学药品 | 片剂 | 10/14/2024 | |
Glipizide Extended Release Tablets | 国药准字HJ20150360 | 化学药品 | 片剂 | 10/14/2024 | |
Glipizide Extended Release Tablets | 国药准字H20223472 | 化学药品 | 片剂 | 7/5/2022 | |
Glipizide Extended Release Tablets | 国药准字H20043436 | 化学药品 | 控释制剂 | 7/22/2020 | |
Glipizide Extended Release Tablets | 国药准字H20084634 | 化学药品 | 片剂 | 4/4/2023 | |
Glipizide Extended Release Tablets | H20150360 | 化学药品 | 片剂 | 4/23/2020 | |
Glipizide Extended Release Tablets | 国药准字H20243032 | 化学药品 | 片剂 | 1/9/2024 | |
Glipizide Extended Release Tablets | 国药准字H20233470 | 化学药品 | 片剂 | 4/17/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
MELIZIDE glipizide 5mg tablet | 46946 | Medicine | A | 11/3/1993 | |
GLIPIDIAB gipizide 5mg tablets blister pack | 170384 | Medicine | A | 8/26/2010 | |
Minidiab | 15421 | Medicine | A | 9/23/1991 | |
GLIPIZIDE tablets 5mg bulk (AF:1) | 90307 | Medicine | A | 7/31/2002 |
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