Drugs / Glipizide
Glipizide
also known as
CP-28,720 · Glibenese · Glipizida · Glipizide component of metaglip · Glipizide slow release · Glucotrol · Glucotrol xl · K 4024 · +3 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | GLUCOTROL XL | — | 1998-02-04 – 2002-04-01 | fda.gov ↗ |
| Approved | US (FDA) | GLUCOTROL | — | 1984-05-08 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials · 2 met primary | ||||||
| Phase 1 | NCT05159427 | Mar 2022 → Mar 2026 | — | University of Michigan | Completed | No outcome recorded |
| Phase 1 | NCT01762046 | Jan 2008 → Dec 2015 | type 2 diabetes mellitus | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00649454 | Jun 2005 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00648505 | Jun 2005 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00834587 | Jun 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00835497 | Jun 2004 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00947024 | Nov 1993 | type 2 diabetes mellitus | Sandoz | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06168812 | Dec 2023 → Dec 2026 expected | pancreatic ductal adenocarcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT00575588 | Dec 2007 → Aug 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00095056 | Oct 2004 → Jul 2006 | chronic renal failure syndrome, type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04239586 | Apr 2017 → Apr 2022 | maturity-onset diabetes of the young type 1, maturity-onset diabetes of the young type 3, type 1 diabetes mellitus | Haukeland University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01951651 | Apr 2010 → Oct 2012 | type 2 diabetes mellitus | Baylor College of Medicine | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06830096 | Mar 2025 → Mar 2026 overdue | type 2 diabetes mellitus | Washington University School of Medicine | Recruiting | No outcome recorded |
| — | NCT02608177 | Nov 2015 → Aug 2017 | chronic kidney disease, type 2 diabetes mellitus | University of Washington | Completed | No outcome recorded |
| — | NCT01082796 | Nov 2009 → Jan 2010 | — | Chinese Academy of Sciences | Completed | No outcome recorded |
| Comparator or background therapy21 trials | ||||||
| Phase 2 | NCT01020123 Comparator | Oct 2009 → Feb 2011 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT01698775 Background | Oct 2012 → Jan 2016 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00885352 Background | Apr 2009 → Nov 2010 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00856284 Comparator | Mar 2009 → Oct 2012 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00707993 Comparator | Jun 2008 → Aug 2010 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 3 | NCT00660907 Comparator | Mar 2008 → Dec 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 3 | NCT00509236 Comparator | Oct 2007 → Mar 2011 | end stage renal failure, type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00509262 Comparator | Oct 2007 → Mar 2011 | chronic kidney disease, type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00350779 Background | Jun 2006 → Sep 2007 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00116831 Comparator | Jan 2005 → Aug 2008 | atherosclerosis | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00094770 Comparator | Sep 2004 → May 2006 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT00086515 Comparator | Jun 2004 → Jul 2005 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 4 | NCT06449235 Comparator | Sep 2024 → Apr 2025 overdue | type 2 diabetes mellitus | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT02911792 Comparator | Dec 2016 → Jul 2023 | type 2 diabetes mellitus | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 4 | NCT01267448 Comparator | Sep 2014 → Jul 2015 | hyperglycemia, type 2 diabetes mellitus | Cook County Health | Completed | No outcome recorded |
| Phase 4 | NCT01758471 Comparator | Dec 2012 → Dec 2013 | type 2 diabetes mellitus | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT00347100 Comparator | Jun 2006 → May 2008 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT00732524 Comparator | Sep 2004 → Apr 2006 | type 2 diabetes mellitus | Cook County Health | Completed | No outcome recorded |
| Phase 4 | NCT00513630 Comparator | Jun 2004 → Jul 2010 | coronary artery disorder, type 2 diabetes mellitus | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| — | NCT00691314 Comparator | Jun 2008 → Sep 2010 | atherosclerosis, transient ischemic attack | Peking Union Medical College Hospital | Completed | No outcome recorded |
| — | NCT00664846 Background | Apr 2008 → Dec 2010 | ischemic stroke | Peking Union Medical College Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2011-06-26 | Bristol-Myers Squibb | Results Investigational Compound Dapagliflozin Added to Metformin Sustained Reductions in Blood Sugar Levels in Adult Patients with Type 2 Diabetes in Two-Year Study bms.com ↗
Episodes of low blood sugar were less frequent in patients treated with dapagliflozin added to metformin than in patients treated with glipizide added to metformin |
| 2011-02-23 | Bristol-Myers Squibb | Results ONGLYZA™ (saxagliptin) U.S. Label Update Provides Further Evidence Regarding Use in Renally Impaired Adults with Type 2 Diabetes bms.com ↗
The data from a separate 52-week study comparing ONGLYZA to titrated glipizide in patients with inadequate glycemic control on metformin therapy plus diet and exercise showed that ONGLYZA plus metformin provided similar HbA1c reductions from baseline. |
| 2010-09-24 | AstraZeneca | Results 52-Week Phase 3 Study Found Investigational Drug Dapagliflozin Plus Metformin Similar to Glipizide Plus Metformin in Improving Glycosylated Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus astrazeneca.com ↗
The study demonstrated dapagliflozin was non-inferior compared to glipizide (sulphonylurea) in improving glycosylated hemoglobin levels (HbA1c) when added to existing metformin therapy during a 52-week treatment period. |
| 2010-09-24 | Bristol-Myers Squibb | Results 52-Week Phase 3 Study Found Investigational Drug Dapagliflozin Plus Metformin Similar to Glipizide Plus Metformin in Improving Glycosylated Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus bms.com ↗
The study demonstrated dapagliflozin was non-inferior compared to glipizide (sulphonylurea) in improving glycosylated hemoglobin levels (HbA1c) when added to existing metformin therapy during a 52-week treatment period. |
| 2010-06-26 | Bristol-Myers Squibb | Results 52-Week Study Finds ONGLYZA™ (saxagliptin) When Added to Metformin Was Non-Inferior to Titrated Glipizide When Added to Metformin in Reducing Glycosylated Hemoglobin (HbA1c) in Adults with Type 2 Diabetes Mellitus bms.com ↗
This study found that the addition of ONGLYZA ™ (saxagliptin) 5 mg to existing metformin therapy achieved the primary objective of demonstrating non-inferiority compared to the addition of titrated glipizide (sulphonylurea) to existing metformin therapy in reducing glycosylated hemoglobin levels (HbA1c). |
| 2005-10-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Glipizide and Metformin HCL Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) today announced that the U.S. Food and Drug Administration has granted final approval for the Company's ANDA for Glipizide and Metformin Hydrochloride Tablets, 2.5 mg/250 mg, 2.5 mg/500 mg, and 5 mg/500 mg. |
All press releases naming this drug 6 releases
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glipizide | “This Arm will include patients receiving Sulphonylureas (Gliclazide/ Glipizide/ Glimepiride/ Tolbutamide) according to the physician's choice.” NCT06449235 ↗35“Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks)” NCT00575588 ↗ “Single dose of Glipizide (5 mg modified-release tablet) and Rifaximin (200 mg tablet)” NCT05159427 ↗ “antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid” NCT00691314 ↗ “antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid” NCT00664846 ↗ “Glipizide” NCT04239586 ↗ |
| Known as | CP-28,720 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | Glibenese | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | Glipizida | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | Glipizide component of metaglip | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | Glipizide slow release | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | Glucotrol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | Glucotrol xl | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | K 4024 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | Minodiab 2.5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | Minodiab 5 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Known as | NSC-759120 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1073 ↗ |
| Action | Inhibit | “glipizide that inhibits KATP channels” NCT06830096 ↗ |
| Modality | Small molecule | “compared with the sulfonylurea glipizide” PMID 20194881 ↗ Mar 2010 |
| Route | Oral | “oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg” NCT00086515 ↗ |