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
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/05 | Phase 2 | Not yet recruiting | |||
2025/06/03 | Phase 4 | Not yet recruiting | |||
2025/05/29 | Phase 2 | Recruiting | Mostafa Bahaa | ||
2025/05/16 | Phase 2 | Not yet recruiting | |||
2025/05/16 | Phase 2 | Not yet recruiting | |||
2025/05/15 | Phase 4 | Not yet recruiting | |||
2025/05/11 | Not Applicable | Not yet recruiting | Leibniz-Institut für Resilienzforschung (LIR) gGmbH | ||
2025/05/07 | Phase 4 | ENROLLING_BY_INVITATION | China-Japan Friendship Hospital | ||
2025/04/29 | Phase 2 | Not yet recruiting | |||
2025/04/22 | Phase 4 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aphena Pharma Solutions - Tennessee, LLC | 71610-613 | ORAL | 500 mg in 1 1 | 3/4/2024 | |
| Aurobindo Pharma Limited | 65862-082 | ORAL | 500 mg in 1 1 | 3/16/2022 | |
| REMEDYREPACK INC. | 70518-3735 | ORAL | 500 mg in 1 1 | 3/28/2024 | |
| NuCare Pharmaceuticals,Inc. | 68071-3833 | ORAL | 850 mg in 1 1 | 4/18/2025 | |
| Merck Sharp & Dohme LLC | 0006-5369 | ORAL | 500 mg in 1 1 | 9/12/2023 | |
| American Health Packaging | 60687-143 | ORAL | 850 mg in 1 1 | 8/30/2023 | |
| Apotheca Inc. | 12634-757 | ORAL | 850 mg in 1 1 | 1/17/2017 | |
| NuCare Pharmaceuticals,Inc. | 68071-4525 | ORAL | 1000 mg in 1 1 | 5/11/2021 | |
| Blenheim Pharmacal, Inc. | 10544-580 | ORAL | 500 mg in 1 1 | 2/18/2015 | |
| AstraZeneca Pharmaceuticals LP | 0310-6225 | ORAL | 1000 mg in 1 1 | 9/12/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/16/2014 | ||
Authorised | 11/14/2007 | ||
Authorised | 11/14/2007 | ||
Authorised | 7/28/2006 | ||
Sun Pharmaceutical Industries Europe B.V.,Polarisavenue 87,2132 JH Hoofddorp,The Netherlands | Authorised | 3/31/2023 | |
Authorised | 3/31/2023 | ||
Authorised | 3/31/2023 | ||
Authorised | 3/23/2018 | ||
Authorised | 7/22/2022 | ||
Authorised | 7/22/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| METFORMIN TABLET 500 mg | SIN04674P | TABLET, FILM COATED | 500 mg | 6/13/1990 | |
| METFORMIN TABLET 500 mg | SIN08764P | TABLET | 500 mg | 7/3/1996 | |
| ADIMET XR TABLET 500MG | SIN16257P | TABLET, FILM COATED, EXTENDED RELEASE | 500mg | 6/30/2021 | |
| GLYFORMIN 500 TABLET 500 mg | SIN06937P | TABLET, FILM COATED | 500 mg | 4/13/1992 | |
| TRAJENTA DUO FILM-COATED TABLETS 2.5MG / 500MG | SIN14377P | TABLET, FILM COATED | 500.000MG | 7/8/2013 | |
| METFORMIN TABLET 250 mg (FILM-COATED) | SIN07751P | TABLET, FILM COATED | 250 mg | 6/21/1994 | |
| DIABETMIN FILM-COATED TABLET 250MG | SIN15032P | TABLET, FILM COATED | 250mg | 6/20/2016 | |
| TRAJENTA DUO FILM-COATED TABLETS 2.5MG /850MG | SIN14378P | TABLET, FILM COATED | 850.000MG | 7/8/2013 | |
| DIABETMIN TABLET 500 mg | SIN04812P | TABLET, FILM COATED | 500.00 mg | 6/26/1990 | |
| MEIJUMET PROLONGED RELEASE TABLET 1000MG | SIN15470P | TABLET, EXTENDED RELEASE | 1000mg | 4/26/2018 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Metformin Hydrochloride Capsules | 国药准字H19991009 | 化学药品 | 胶囊剂 | 6/15/2020 | |
| Metformin Hydrochloride Enteric-Coated Capsules | 国药准字H20065996 | 化学药品 | 胶囊剂 | 6/2/2021 | |
| Metformin Hydrochloride Enteric-Coated Capsules | 国药准字H20058567 | 化学药品 | 胶囊剂 | 3/24/2020 | |
| Metformin Hydrochloride Enteric-Coated Capsules | 国药准字H20094132 | 化学药品 | 胶囊剂 | 9/27/2019 | |
| Metformin Hydrochloride Enteric-Coated Capsules | 国药准字H20060728 | 化学药品 | 胶囊剂(肠溶) | 6/10/2020 | |
| Metformin Hydrochloride Enteric-Coated Capsules | 国药准字H10980064 | 化学药品 | 胶囊剂 | 3/24/2020 | |
| Metformin Hydrochloride Enteric-Coated Capsules | 国药准字H20103017 | 化学药品 | 胶囊剂 | 5/23/2024 | |
| Metformin Hydrochloride Sustained-release Capsules | 国药准字H20051722 | 化学药品 | 胶囊剂 | 4/24/2020 | |
| Metformin Hydrochloride Sustained-release Capsules | 国药准字H20051805 | 化学药品 | 胶囊剂 | 5/12/2020 | |
| Metformin Hydrochloride Sustained-release Capsules | 国药准字H20080725 | 化学药品 | 胶囊剂 | 12/7/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| GALVUSMET TAB 50/850MG | N/A | N/A | N/A | 12/30/2009 | |
| GLUCOFIT TABLETS 500MG | N/A | wilcome pharmaceutical co ltd | N/A | N/A | 8/8/2016 |
| GLUCOMILL XR PROLONGED RELEASE TABLETS 1000MG | N/A | N/A | N/A | 10/9/2024 | |
| TRAJENTA DUO TAB 2.5/850MG | N/A | boehringer ingelheim (hk) ltd | N/A | N/A | 5/20/2013 |
| SITAGLIPTIN/METFORMIN SANDOZ TABLETS 50MG/1000MG | N/A | N/A | N/A | 2/13/2025 | |
| DIABETMIN TAB 500MG | N/A | N/A | N/A | 1/24/1992 | |
| JARDIANCE DUO TABLETS 5MG/500MG | N/A | boehringer ingelheim (hk) ltd | N/A | N/A | 3/3/2017 |
| RISIDON TABLETS 500MG | N/A | N/A | N/A | 7/4/2017 | |
| LVTANGSU TABLETS 500MG | N/A | hitpharm pharmaceutical co ltd | N/A | N/A | 1/11/2017 |
| JARDIANCE DUO TABLETS 12.5MG/500MG | N/A | boehringer ingelheim (hk) ltd | N/A | N/A | 3/3/2017 |