Overview
First introduced in 1995, glimepiride is a member of the second-generation sulfonylurea (SU) drug class used for the management of type 2 diabetes mellitus (T2DM) to improve glycemic control. Type 2 diabetes is a metabolic disorder with increasing prevalences worldwide; it is characterized by insulin resistance in accordance with progressive β cell failure and long-term microvascular and macrovascular complications that lead to co-morbidities and mortalities. Sulfonylureas are one of the insulin secretagogues widely used for the management of type 2 diabetes to lower blood glucose levels. The main effect of SUs is thought to be effective when residual pancreatic β-cells are present, as they work by stimulating the release of insulin from the pancreatic beta cells and they are also thought to exert extra-pancreatic effects, such as increasing the insulin-mediated peripheral glucose uptake. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (K channels) and causing depolarization of the beta cells. Compared to glipizide, another second SU drug, glimepiride has a longer duration of action. It is sometimes classified as a third-generation SU because it has larger substitutions than other second-generation SUs. Compared to other SUs, glimepiride was associated with a lower risk of developing hypoglycemia and weight gain in clinical trials as well as fewer cardiovascular effects than other SUs due to minimal effects on ischemic preconditioning of cardiac myocytes. It is effective in reducing fasting plasma glucose, postprandial glucose, and glycosylated hemoglobin levels and is considered to be a useful, cost-effective treatment option for managing type 2 diabetes mellitus. Glimepiride was approved by the Food and Drug Administration (FDA) in the United States in 1995 for the treatment of T2DM. It is commonly marketed under the brand name Amaryl as oral tablets and is typically administered once daily.
Background
First introduced in 1995, glimepiride is a member of the second-generation sulfonylurea (SU) drug class used for the management of type 2 diabetes mellitus (T2DM) to improve glycemic control. Type 2 diabetes is a metabolic disorder with increasing prevalences worldwide; it is characterized by insulin resistance in accordance with progressive β cell failure and long-term microvascular and macrovascular complications that lead to co-morbidities and mortalities. Sulfonylureas are one of the insulin secretagogues widely used for the management of type 2 diabetes to lower blood glucose levels. The main effect of SUs is thought to be effective when residual pancreatic β-cells are present, as they work by stimulating the release of insulin from the pancreatic beta cells and they are also thought to exert extra-pancreatic effects, such as increasing the insulin-mediated peripheral glucose uptake. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (K channels) and causing depolarization of the beta cells. Compared to glipizide, another second SU drug, glimepiride has a longer duration of action. It is sometimes classified as a third-generation SU because it has larger substitutions than other second-generation SUs. Compared to other SUs, glimepiride was associated with a lower risk of developing hypoglycemia and weight gain in clinical trials as well as fewer cardiovascular effects than other SUs due to minimal effects on ischemic preconditioning of cardiac myocytes. It is effective in reducing fasting plasma glucose, postprandial glucose, and glycosylated hemoglobin levels and is considered to be a useful, cost-effective treatment option for managing type 2 diabetes mellitus. Glimepiride was approved by the Food and Drug Administration (FDA) in the United States in 1995 for the treatment of T2DM. It is commonly marketed under the brand name Amaryl as oral tablets and is typically administered once daily.
Indication
Glimepiride is indicated for the management of type 2 diabetes in adults as an adjunct to diet and exercise to improve glycemic control as monotherapy. It may also be indicated for use in combination with metformin or insulin to lower blood glucose in patients with type 2 diabetes whose high blood sugar levels cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic (a drug used to lower blood sugar levels) agent alone.
Associated Conditions
- Type 2 Diabetes Mellitus
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2023/10/05 | Not Applicable | Completed | |||
2023/08/04 | Phase 4 | Recruiting | |||
2022/12/23 | Phase 4 | Recruiting | |||
2022/09/14 | N/A | Completed | Dao Wen Wang | ||
2022/07/21 | Not Applicable | Completed | PT Harsen Laboratories | ||
2022/05/23 | Phase 4 | UNKNOWN | |||
2021/12/17 | N/A | Completed | |||
2021/10/29 | N/A | Completed | |||
2021/10/11 | N/A | Recruiting | |||
2020/08/27 | Phase 4 | Completed | Rehab Werida |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
NuCare Pharmaceuticals, Inc. | 68071-1910 | ORAL | 2 mg in 1 1 | 2/22/2021 | |
Preferred Pharmaceuticals Inc. | 68788-8066 | ORAL | 4 mg in 1 1 | 7/11/2023 | |
Accord Healthcare Inc | 16729-003 | ORAL | 4 mg in 1 1 | 11/28/2023 | |
Rising Pharma Holdings, Inc. | 16571-775 | ORAL | 4 mg in 1 1 | 10/30/2023 | |
Golden State Medical Supply, Inc. | 60429-919 | ORAL | 2 mg in 1 1 | 2/21/2024 | |
Micro Labs Limited | 42571-104 | ORAL | 6 mg in 1 1 | 12/2/2021 | |
Legacy Pharmaceutical Packaging, LLC | 68645-573 | ORAL | 4 mg in 1 1 | 12/13/2023 | |
Proficient Rx LP | 63187-698 | ORAL | 1 mg in 1 1 | 10/1/2022 | |
Northwind Pharmaceuticals, LLC | 51655-120 | ORAL | 4 mg in 1 1 | 1/20/2023 | |
Accord Healthcare Inc | 16729-002 | ORAL | 2 mg in 1 1 | 11/28/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 1/8/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
AMARYL 2.0 TABLETS 2 mg | SIN10459P | TABLET | 2 mg | 11/20/1998 | |
AMARYL 1.0 TABLETS 1 mg | SIN10460P | TABLET | 1 mg | 11/20/1998 | |
DIALOSA TABLET 3MG | SIN13674P | TABLET | 3MG | 7/20/2009 | |
AMARYL 3.0 TABLETS 3 mg | SIN10462P | TABLET | 3 mg | 11/20/1998 | |
DIALOSA TABLET 2MG | SIN13675P | TABLET | 2.00MG | 7/20/2009 | |
DIAPRIDE-1 TABLET 1 mg | SIN12367P | TABLET | 1 mg | 7/24/2003 | |
DIAPRIDE-2 TABLET 2 mg | SIN12366P | TABLET | 2 mg | 7/24/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Glimepiride Orally Disintegrating Tablets | 国药准字H20080704 | 化学药品 | 片剂 | 1/5/2023 | |
Glimepiride Pills | 国药准字H20041773 | 化学药品 | 滴丸剂 | 2/6/2020 | |
Glimepiride Dispersible Tablets | 国药准字H20140088 | 化学药品 | 片剂 | 6/3/2024 | |
Glimepiride Dispersible Tablets | 国药准字H20140087 | 化学药品 | 片剂 | 6/3/2024 | |
Glimepiride Dispersible Tablets | 国药准字H20100183 | 化学药品 | 片剂 | 10/23/2020 | |
Glimepiride Dispersible Tablets | 国药准字H20100182 | 化学药品 | 片剂 | 10/23/2020 | |
Glimepiride Tablets | 国药准字H20031079 | 化学药品 | 片剂 | 8/13/2020 | |
Glimepiride Tablets | 国药准字H20205029 | 化学药品 | 片剂 | 5/27/2022 | |
Glimepiride Tablets | 国药准字H20010569 | 化学药品 | 片剂 | 1/9/2020 | |
Glimepiride Tablets | 国药准字H20010575 | 化学药品 | 片剂 | 8/13/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
GLIMARYL TAB 2MG | N/A | N/A | N/A | 2/9/2009 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
GLIRIDE 4mg glimepiride tablet 4mg blister pack | 259463 | Medicine | A | 8/3/2016 | |
NECARAL 1mg glimepiride tablet 1mg blister pack | 259467 | Medicine | A | 8/3/2016 | |
DIAPRIDE 1 glimepiride 1mg tablet blister pack | 107344 | Medicine | A | 7/22/2005 | |
GLIMEPIRIDE B&B 4mg glimepiride tablet 4mg blister pack | 259465 | Medicine | A | 8/3/2016 | |
GLIMEPIRIDE INTAS glimepiride 2mg tablet blister pack | 281219 | Medicine | A | 3/17/2017 | |
ARX-GLIMEPIRIDE glimepiride 1mg tablet blister pack | 281224 | Medicine | A | 3/17/2017 | |
GLIMIRIDE 3mg glimepiride tablet 3mg blister pack | 259460 | Medicine | A | 8/3/2016 | |
SIGMARYL 2 | 189581 | Medicine | A | 9/15/2011 | |
SIGMARYL 4 | 189582 | Medicine | A | 9/15/2011 | |
ARX-GLIMEPIRIDE glimepiride 3mg tablet blister pack | 281226 | Medicine | A | 3/17/2017 |