Overview
Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels. Another well-known benefit of this drug is modest weight loss, making it an effective choice for obese patients type II diabetes. Metformin was first approved in Canada in 1972, and received subsequent FDA approval in the US in 1995.
Background
Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels. Another well-known benefit of this drug is modest weight loss, making it an effective choice for obese patients type II diabetes. Metformin was first approved in Canada in 1972, and received subsequent FDA approval in the US in 1995.
Indication
Metformin immediate-release formulations Metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10 years old with type 2 diabetes mellitus. Metformin extended-release tablet (XR) The extended-release formulation of metformin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Safety in children has not been determined to this date. Metformin combination products Metformin is a component of a variety of combination products with other anti-diabetic agents. It is indicated, along with diet and exercise, to improve glycemic control in adult patients with type 2 diabetes mellitus in combination with DPP-4 inhibitors (sitagliptin, linagliptin, alogliptin, or saxagliptin), in combination with SGLT2 inhibitors (canagliflozin, empagliflozin, ertugliflozin, or dapagliflozin), or in combination with pioglitazone.
Associated Conditions
- Cardiovascular Mortality
- End Stage Renal Disease (ESRD)
- Hospitalizations
- Polycystic Ovarian Syndrome (PCOS)
- Type 2 Diabetes Mellitus
- Decreased estimated glomerular filtration rate
Research Report
Metformin Report
Name: Metformin Name (English): Metformin DrugBank ID: DB00331 Type: Small Molecule CAS Number: 657-24-9
General Information: Metformin is an oral antihyperglycemic agent of the biguanide class, primarily used in the management of type 2 diabetes mellitus. It is often considered the first-line medication for this condition, especially in overweight individuals. Metformin can also be used off-label for insulin resistance in polycystic ovary syndrome (PCOS).
Pharmacology: Metformin works by:
- Decreasing hepatic glucose production.
- Increasing insulin sensitivity in peripheral tissues.
- Improving glucose uptake and utilization.
- Increasing GDF15 secretion, which reduces appetite and caloric intake.
Indications:
- Type 2 diabetes mellitus in adults and pediatric patients ≥10 years old, as an adjunct to diet and exercise.
- May be used as a second-line agent for infertility in women with PCOS.
- Investigational use for other conditions such as type 1 diabetes, obesity, and various cancers is ongoing.
Dosage and Administration: Dosage varies depending on the formulation (immediate-release or extended-release) and individual patient needs. It is typically taken with meals to reduce gastrointestinal side effects.
Contraindications:
- Severe renal impairment (eGFR below 30 mL/min/1.73 m²)
- Hypersensitivity to metformin
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/03/22 | Not Applicable | Completed | |||
2024/03/22 | Not Applicable | Recruiting | Shanghai 10th People's Hospital | ||
2024/03/19 | Not Applicable | Recruiting | |||
2024/03/06 | Phase 4 | Recruiting | |||
2024/02/28 | Phase 4 | Recruiting | |||
2024/02/22 | Phase 2 | Recruiting | |||
2024/02/20 | Phase 4 | Completed | HÜMEYRA ACIKAN | ||
2024/02/14 | Phase 3 | Recruiting | Beijing Dongfang Biotech Co., Ltd. | ||
2024/02/13 | Phase 4 | Not yet recruiting | Ping Li,MD | ||
2024/02/09 | Phase 2 | Recruiting | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aurobindo Pharma Limited | 65862-081 | ORAL | 500 mg in 1 1 | 3/16/2022 | |
| RPK Pharmaceuticals, Inc. | 53002-4422 | ORAL | 850 mg in 1 1 | 2/7/2017 | |
| Laurus Labs Limited | 42385-949 | ORAL | 1000 mg in 1 1 | 9/21/2023 | |
| State of Florida DOH Central Pharmacy | 53808-0848 | ORAL | 1000 mg in 1 1 | 4/15/2014 | |
| Mylan Pharmaceuticals Inc. | 0378-6001 | ORAL | 1000 mg in 1 1 | 5/25/2017 | |
| Northwind Pharmaceuticals | 51655-562 | ORAL | 750 mg in 1 1 | 6/19/2014 | |
| direct rx | 72189-064 | ORAL | 500 mg in 1 1 | 10/11/2022 | |
| REMEDYREPACK INC. | 70518-3260 | ORAL | 500 mg in 1 1 | 3/14/2024 | |
| Preferred Pharmaceuticals Inc | 68788-7901 | ORAL | 850 mg in 1 1 | 7/28/2023 | |
| Quallent Pharmaceuticals Health LLC | 82009-046 | ORAL | 500 mg in 1 1 | 7/27/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Metformin Hydrochloride Sustained-release Tablets | 国药准字H20051187 | 化学药品 | 片剂 | 3/20/2020 | |
| Metformin Hydrochloride Sustained-release Tablets | 国药准字H20060815 | 化学药品 | 片剂 | 6/3/2021 | |
| Metformin Hydrochloride Sustained-release Tablets | 国药准字H20040154 | 化学药品 | 片剂 | 2/12/2020 | |
| Metformin Hydrochloride Sustained-release Tablets | 国药准字H20041986 | 化学药品 | 片剂 | 3/20/2020 | |
| Metformin Hydrochloride Sustained-release Tablets | 国药准字H20203371 | 化学药品 | 片剂 | 7/29/2020 | |
| Metformin Hydrochloride Sustained-release Tablets | 国药准字H20060226 | 化学药品 | 片剂(缓释) | 12/30/2020 | |
| Metformin Hydrochloride Sustained-release Tablets | 国药准字H20080279 | 化学药品 | 片剂 | 3/1/2023 | |
| Metformin Hydrochloride Sustained-release Tablets | 国药准字H20213623 | 化学药品 | 片剂 | 7/28/2021 | |
| Metformin Hydrochloride Sustained-release Tablets | 国药准字H20254325 | 化学药品 | 片剂 | 5/27/2025 | |
| Metformin Hydrochloride Enteric-coated Tablets | 国药准字H20073383 | 化学药品 | 片剂 | 6/7/2024 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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