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

Drug Type: Small Molecule

Chemical Formula: C_₄H_₁₁N_₅

CAS Number: 657-24-9

Unique Ingredient Identifier: 9100L32L2N

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

Associated Therapies: -

Clinical Trials

Glycemic Excursions in Type 2 Diabetic Patients With Vildagliptin and Metformin Versus Vildagliptin and Glimepiride

Phase 4

Completed

Conditions: Hypoglycemia
Type 2 Diabetes

Interventions: Drug: vildagliptin and metformin (combination)
Drug: glimepiride
Drug: Metformin

First Posted Date: 2013-12-10

Last Posted Date: 2017-07-11

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 40

Registration Number: NCT02007278

Locations: 🇨🇴
Novartis Investigative Site, Monteria, Colombia

Metformin Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection

Phase 2

Completed

Conditions: Stage IA Pancreatic Adenocarcinoma
Stage IB Pancreatic Adenocarcinoma
Stage IIA Pancreatic Adenocarcinoma
Stage IIB Pancreatic Adenocarcinoma

Interventions: Drug: Gemcitabine
Drug: placebo
Drug: Metformin

First Posted Date: 2013-12-09

Last Posted Date: 2019-02-05

Lead Sponsor: Xian-Jun Yu

Target Recruit Count: 300

Registration Number: NCT02005419

Locations: 🇨🇳
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University, Shanghai, China

A Study to Assess the Safety, Tolerability and Glucose-Lowering Efficacy of MK-0893 in Participants With Type 2 Diabetes Mellitus (MK-0893-005)

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: MK-0893
Drug: Metformin
Drug: Placebo

First Posted Date: 2013-12-09

Last Posted Date: 2018-09-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 74

Registration Number: NCT02004886

Study of Efficacy and Safety of Vildagliptin as add-on Insulin Therapy in T2DM Patients

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus (T2DM)

Interventions: Drug: Placebo
Drug: Vildagliptin (LAF237)
Drug: Insulin
Drug: Metformin

First Posted Date: 2013-12-05

Last Posted Date: 2016-03-01

Lead Sponsor: Novartis Pharmaceuticals

Target Recruit Count: 156

Registration Number: NCT02002221

Locations: 🇯🇵
Novartis Investigative Site, Suginami-ku, Tokyo, Japan

Ertugliflozin vs. Glimepiride in Type 2 Diabetes Mellitus (T2DM) Participants on Metformin (MK-8835-002)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Ertugliflozin 5 mg
Drug: Glimerpiride
Drug: Placebo to Ertugliflozin
Drug: Ertugliflozin 10 mg
Drug: Placebo to Glimepiride
Drug: Metformin
Drug: Sitagliptin

First Posted Date: 2013-12-03

Last Posted Date: 2019-04-02

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1326

Registration Number: NCT01999218

Metformin in Stage IV Lung Adenocarcinoma

Phase 2

Terminated

Conditions: Non-small Cell Lung Cancer

Interventions: Drug: METFORMIN

First Posted Date: 2013-11-28

Last Posted Date: 2016-09-30

Lead Sponsor: National Cheng-Kung University Hospital

Target Recruit Count: 13

Registration Number: NCT01997775

Locations: 🇨🇳
National Cheng-Kung Uni. Hosp., Tainan, Taiwan

Prevention of Metabolic Syndrome and Increased Weight Using Metformin Concurrent to Androgen Deprivation Therapy and Radiotherapy for Locally Advanced Adenocarcinoma of the Prostate

Phase 2

Terminated

Conditions: Prostatic Neoplasm

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2013-11-27

Last Posted Date: 2024-01-30

Lead Sponsor: AHS Cancer Control Alberta

Target Recruit Count: 83

Registration Number: NCT01996696

Locations: 🇨🇦
Prairie Mountain Health - Western Manitoba Cancer Centre, Brandon, Manitoba, Canada
🇨🇦
CancerCare Manitoba, Winnipeg, Manitoba, Canada
🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada