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

A Study in Participants With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: LY2189265
Drug: Exenatide
Drug: Placebo
Drug: Metformin
Drug: Pioglitazone

First Posted Date: 2010-02-08

Last Posted Date: 2015-01-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 978

Registration Number: NCT01064687

Locations: 🇵🇷
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Yabucoa, Puerto Rico

Study Of Safety And Efficacy Of Ertugliflozin (PF-04971729, MK-8835) In Participants With Type 2 Diabetes (MK-8835-016)

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo to Ertugliflozin
Drug: Ertugliflozin 5 mg
Drug: Placebo to Sitagliptin
Drug: Ertugliflozin 1 mg
Drug: Ertugliflozin 25 mg
Drug: Sitagliptin 100 mg
Drug: Metformin

First Posted Date: 2010-02-01

Last Posted Date: 2018-09-13

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 375

Registration Number: NCT01059825

A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Dapagliflozin/Metformin
Drug: Dapagliflozin
Drug: Metformin

First Posted Date: 2010-01-26

Last Posted Date: 2012-06-01

Lead Sponsor: AstraZeneca

Target Recruit Count: 120

Registration Number: NCT01055691

Locations: 🇩🇪
Research Site, Berlin, Germany

A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

Phase 3

Terminated

Conditions: Diabetes Mellitus Type 2

Interventions: Drug: metformin
Drug: insulin glargine
Drug: taspoglutide

First Posted Date: 2010-01-18

Last Posted Date: 2016-11-02

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 370

Registration Number: NCT01051011

Safety Study of BMS-770767 in Subjects With Type 2 Diabetes

Phase 2

Completed

Conditions: Diabetes Type 2

Interventions: Drug: BMS-770767
Drug: Placebo
Drug: Metformin

First Posted Date: 2010-01-12

Last Posted Date: 2015-10-12

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 76

Registration Number: NCT01046422

Locations: 🇺🇸
Nevada Alliance Against Diabetes, Las Vegas, Nevada, United States
🇺🇸
Marina Raikhel, Md, Lomita, California, United States
🇰🇷
Local Institution, Suwon, Korea, Republic of

Myo-inositol Versus Metformin Administration in Post-menopausal Women With Metabolic Syndrome

Phase 2

Conditions: Metabolic Syndrome

Interventions: Dietary Supplement: myo-inositol
Drug: Metformin

First Posted Date: 2010-01-12

Last Posted Date: 2014-05-20

Lead Sponsor: University of Messina

Target Recruit Count: 100

Registration Number: NCT01046500

Locations: 🇮🇹
University Hospital, Messina, Italy

Metformin Treatment Before in Vitro Fertilization (IVF) in Women With Ultrasound Evidence of Polycystic Ovaries

Not Applicable

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2010-01-11

Last Posted Date: 2010-01-11

Lead Sponsor: University of Oxford

Target Recruit Count: 134

Registration Number: NCT01046032

Locations: 🇬🇧
IVF Hammersmith, London, United Kingdom
🇬🇧
Nuture IVF Unit, Nottingham, United Kingdom
🇬🇧
Oxford Fertility Unit, Oxford, United Kingdom