Metformin
- Generic Name
- Metformin
- Brand Names
- Actoplus Met, Avandamet, Fortamet, Glucophage, Glucovance, Glumetza, Glycon, Invokamet, Janumet, Jentadueto, Kazano, Kombiglyze, Komboglyze, Qternmet, Riomet, Segluromet, Synjardy, Trijardy, Velmetia, Xigduo, Sitagliptin / Metformin hydrochloride Accord, Vildagliptin / Metformin hydrochloride Accord, Vokanamet, Sitagliptin / Metformin hydrochloride Mylan, Efficib
- Drug Type
- Small Molecule
- Chemical Formula
- C4H11N5
- CAS Number
- 657-24-9
- Unique Ingredient Identifier
- 9100L32L2N
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 |
|---|---|---|---|---|---|
2023/02/23 | Not Applicable | Completed | |||
2023/02/23 | N/A | Completed | Pasquale Mone | ||
2023/02/10 | Phase 3 | Completed | |||
2023/02/01 | Phase 3 | Active, not recruiting | |||
2023/01/27 | Phase 4 | Recruiting | |||
2023/01/23 | Phase 1 | Completed | Shanghai Yinnuo Pharmaceutical Technology Co., Ltd. | ||
2023/01/11 | Phase 4 | Recruiting | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | ||
2023/01/11 | Phase 3 | Completed | |||
2022/12/23 | Phase 4 | Completed | All India Institute of Medical Sciences, Bhubaneswar | ||
2022/12/19 | Phase 4 | Not yet recruiting |
FDA Approved Products
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Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
Physicians Total Care, Inc. | ORAL | 500 mg in 1 1 | 2011/12/20 | 54868-5148 | |
ORAL | 500 mg in 1 1 | 2021/11/24 | 67877-217 | ||
Granules Pharmaceuticals Inc. | ORAL | 850 mg in 1 1 | 2023/08/09 | 70010-064 | |
ORAL | 500 mg in 1 1 | 2024/01/15 | 70518-3599 | ||
A-S Medication Solutions | ORAL | 500 mg in 1 1 | 2018/08/02 | 50090-0771 | |
ORAL | 1000 mg in 1 1 | 2022/11/03 | 71610-673 | ||
Physicians Total Care, Inc. | ORAL | 500 mg in 1 1 | 2011/12/20 | 54868-5243 | |
ORAL | 500 mg in 1 1 | 2022/06/23 | 25000-101 | ||
ORAL | 850 mg in 1 1 | 2010/08/09 | 53808-0717 | ||
ORAL | 1000 mg in 1 1 | 2023/09/26 | 43063-544 |
EMA Approved Products
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Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
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Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|
No HSA products found
No HSA products found for this drug
NMPA Approved Products
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Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字HJ20200040 | 片剂 | N/A | 0.5g | Chemical Drug | Approved | 2020/09/30 | Import | ||
国药准字H20227136 | 片剂 | N/A | 0.25g | Chemical Drug | Approved | 2022/10/18 | Domestic | ||
国药准字H20203366 | 片剂 | N/A | 0.85g | Chemical Drug | Approved | 2020/07/29 | Domestic | ||
国药准字H41024137 | 片剂 | N/A | 0.25g | Chemical Drug | Approved | 2020/01/14 | Domestic | ||
国药准字H20203661 | 片剂 | N/A | 1.0g | Chemical Drug | Approved | 2020/12/08 | Domestic | ||
国药准字H14020843 | 片剂 | N/A | 0.25g | Chemical Drug | Approved | 2020/04/10 | Domestic | ||
国药准字H20184130 | 片剂 | N/A | 0.25g | Chemical Drug | Approved | 2023/09/13 | Domestic | ||
国药准字H21022377 | 片剂 | N/A | 0.25g | Chemical Drug | Approved | 2020/06/15 | Domestic | ||
国药准字H11020596 | 片剂(薄膜衣) | N/A | 0.25g | Chemical Drug | Approved | 2020/12/04 | Domestic | ||
国药准字H31021359 | 片剂 | N/A | 0.25g | Chemical Drug | Approved | 2019/11/26 | Domestic |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
|---|---|---|---|---|---|
HK-59044 | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2009/12/30 | ||
HK-64639 | wilcome pharmaceutical co ltd | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2016/08/08 | |
HK-68391 | CHEMILL PHARMA LIMITED | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2024/10/09 | |
HK-61966 | boehringer ingelheim (hk) ltd | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2013/05/20 | |
HK-68568 | Sandoz Hong Kong Limited | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2025/02/13 | |
HK-35641 | HOVID LIMITED | Part 1, Schedule 1 & Schedule 3 Poison | POM | 1992/01/24 | |
HK-65020 | boehringer ingelheim (hk) ltd | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2017/03/03 | |
HK-65243 | MERCK PHARMACEUTICAL (HK) LIMITED | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2017/07/04 | |
HK-64949 | hitpharm pharmaceutical co ltd | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2017/01/11 | |
HK-65019 | boehringer ingelheim (hk) ltd | Part 1, Schedule 1 & Schedule 3 Poison | POM | 2017/03/03 |
TGA Approved Products
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Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
386882 | Active | 2023/04/06 | metformin hydrochloride | ||
335859 | Active | 2020/06/23 | metformin hydrochloride | ||
40806 | Active | 1992/08/13 | metformin hydrochloride | ||
149021 | Active | 2009/04/30 | metformin hydrochloride | ||
100285 | Active | 2004/11/15 | metformin hydrochloride | ||
91112 | Active | 2002/10/31 | metformin hydrochloride | ||
197403 | Active | 2013/01/25 | metformin hydrochloride | ||
211295 | Active | 2014/07/18 | metformin hydrochloride | ||
232648 | Active | 2015/09/10 | metformin hydrochloride | ||
324039 | Pharmacor Pty Ltd | Active | 2020/10/16 | metformin hydrochloride |