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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
C4H11N5
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
-

A Study of RO5095932 in Patients With Type 2 Diabetes Mellitus

Phase 1
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: RO5095932
Drug: metformin
Drug: placebo
First Posted Date
2009-08-19
Last Posted Date
2016-11-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
122
Registration Number
NCT00961909

A Trial Comparing Two Therapies: Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET) or Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT) in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2009-08-18
Last Posted Date
2015-04-07
Lead Sponsor
AstraZeneca
Target Recruit Count
1036
Registration Number
NCT00960661
Locations
🇬🇧

Research Site, Wakefield, United Kingdom

Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Diabetes
Interventions
Drug: repaglinide and metformin combination tablet
Drug: repaglinide
Drug: metformin
First Posted Date
2009-08-14
Last Posted Date
2015-03-24
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
42
Registration Number
NCT00959101

The Effect of Welchol on Glucose Metabolism in Type 2 Diabetics

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: Colesevelam
Other: Placebo
Behavioral: Diet
Drug: Metformin
First Posted Date
2009-08-04
Last Posted Date
2013-11-11
Lead Sponsor
Mayo Clinic
Target Recruit Count
38
Registration Number
NCT00951899
Locations
🇺🇸

Mayo Clinic, Rochester, Minnesota, United States

PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives

Phase 3
Completed
Conditions
Polycystic Ovarian Syndrome
Insulin Sensitivity
Interventions
Drug: oral contraceptive
Drug: Metformin
First Posted Date
2009-07-29
Last Posted Date
2009-10-14
Lead Sponsor
Federico II University
Target Recruit Count
20
Registration Number
NCT00948402

Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects

Phase 1
Completed
Conditions
Healthy
First Posted Date
2009-07-23
Last Posted Date
2009-07-23
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT00944346
Locations
🇺🇸

Gateway Medical Research, Inc., St, Charles, Missouri, United States

Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fasted, Healthy, Adult Subjects

Phase 1
Completed
Conditions
Healthy
First Posted Date
2009-07-23
Last Posted Date
2009-07-23
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT00944177
Locations
🇺🇸

Gateway Medical Research, Inc., St, Charles, Missouri, United States

Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients

Phase 3
Conditions
Obesity
Interventions
Drug: Sibutramine-Metformin
Drug: Sibutramine
Drug: Metformin
First Posted Date
2009-07-17
Last Posted Date
2009-07-17
Lead Sponsor
Laboratorios Silanes S.A. de C.V.
Target Recruit Count
60
Registration Number
NCT00941382
Locations
🇲🇽

Centro Universitario de Ciencias de la Salud, Guadalajara, Jalisco, Mexico

Beta-Cell Function of Insulin Glargine Compared to Neutral Protamine Hagedorn (NPH) Insuline and to Insulin Detemir in Combination With Metformin

Phase 4
Completed
Conditions
Type 2 Diabetic Patients
Insufficient Metabolic Control
OAD Treatment
Interventions
Drug: Insulin Glargin
Drug: NPH insulin
Drug: Insulin detemir
Drug: metformin
First Posted Date
2009-07-17
Last Posted Date
2009-07-17
Lead Sponsor
ikfe-CRO GmbH
Target Recruit Count
30
Registration Number
NCT00941148
Locations
🇩🇪

ikfe GmbH, Clinic Department, Mainz, RLP, Germany

Tolerability and Pharmacokinetics of Metformin and Metformin Extended Release (ER)

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: metformin ER
Drug: metformin
First Posted Date
2009-07-17
Last Posted Date
2018-01-30
Lead Sponsor
Laboratorios Silanes S.A. de C.V.
Target Recruit Count
24
Registration Number
NCT00941239
Locations
🇲🇽

Pharmacology and toxicology department, UANL, Monterrey, Nuevo León, Mexico

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