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 |
|---|---|---|---|---|---|
2019/06/10 | Phase 4 | UNKNOWN | |||
2019/06/04 | Phase 2 | Recruiting | Lille Catholic University | ||
2019/05/30 | Phase 2 | UNKNOWN | Centro Medico Nacional Siglo XXI IMSS | ||
2019/04/26 | Phase 4 | Completed | Kasr El Aini Hospital | ||
2019/04/24 | Phase 3 | Recruiting | Sherief Abd-Elsalam | ||
2019/04/19 | N/A | Completed | |||
2019/04/16 | Early Phase 1 | Completed | |||
2019/04/08 | Early Phase 1 | Recruiting | |||
2019/04/01 | Not Applicable | Completed | Reproductive & Genetic Hospital of CITIC-Xiangya | ||
2019/03/26 | Phase 1 | Active, not recruiting | Danae Hamouda, MD |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| St. Mary's Medical Park Pharmacy | 60760-523 | ORAL | 500 mg in 1 1 | 5/12/2022 | |
| REMEDYREPACK INC. | 70518-0373 | ORAL | 500 mg in 1 1 | 1/5/2024 | |
| NuCare Pharmaceuticals,Inc. | 68071-4560 | ORAL | 500 mg in 1 1 | 2/18/2021 | |
| RedPharm Drug, Inc. | 67296-1701 | ORAL | 500 mg in 1 1 | 1/14/2021 | |
| Aphena Pharma Solutions - Tennessee, LLC | 43353-340 | ORAL | 500 mg in 1 1 | 6/25/2014 | |
| Merck Sharp & Dohme LLC | 0006-0575 | ORAL | 500 mg in 1 1 | 7/22/2022 | |
| ScieGen Pharmaceuticals Inc | 50228-105 | ORAL | 500 mg in 1 1 | 1/9/2023 | |
| LifSa Drugs, LLC | 72336-064 | ORAL | 625 mg in 1 1 | 7/6/2023 | |
| Amneal Pharmaceuticals of New York LLC | 53746-178 | ORAL | 500 mg in 1 1 | 3/18/2021 | |
| RedPharm Drug, Inc. | 67296-1711 | ORAL | 500 mg in 1 1 | 1/14/2021 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||