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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
-

Dapagliflozin Effects on Epicardial Fat

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2014-09-09
Last Posted Date
2021-02-16
Lead Sponsor
University of Miami
Target Recruit Count
100
Registration Number
NCT02235298
Locations
🇺🇸

University of Miami, Miami, Florida, United States

Effect of Metformin on Disease Progression in Patients With Cryptogenic Cirrhosis (NASH-related Cirrhosis) With Diabetes or Impaired Glucose Tolerance or Insulin Resistance

Not Applicable
Completed
Conditions
NASH Related Cirrhosis
Interventions
Drug: Insulin
Drug: Metformin
First Posted Date
2014-09-09
Last Posted Date
2018-02-08
Lead Sponsor
Institute of Liver and Biliary Sciences, India
Target Recruit Count
86
Registration Number
NCT02234440
Locations
🇮🇳

Institute of Liver & Biliary Sciences, New Delhi, Delhi, India

Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin

First Posted Date
2014-09-04
Last Posted Date
2023-10-24
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
24
Registration Number
NCT02231931
Locations
🇩🇪

352.2082.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: empagliflozin/metformin
Drug: metformin
Drug: empagliflozin
First Posted Date
2014-09-03
Last Posted Date
2017-03-09
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
30
Registration Number
NCT02230995
Locations
🇩🇪

Boehringer Ingelheim Investigational Site, Biberach an der Riss, Germany

Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Linagliptin/Metformin FDC
Drug: Linagliptin
Drug: Metformin
First Posted Date
2014-08-20
Last Posted Date
2014-08-20
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
96
Registration Number
NCT02220647

Bioequivalence of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Linagliptin/Metformin FDC
Drug: Linagliptin
Drug: Metformin
First Posted Date
2014-08-20
Last Posted Date
2014-08-20
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
95
Registration Number
NCT02221414

Bioequivalence of a Linagliptin / Metformin Fixed-dose Combination (FDC) Tablet Compared With Single Linagliptin and Metformin Tablets Administered Together in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Linagliptin/Metformin FDC
Drug: Linagliptin
Drug: Metformin
First Posted Date
2014-08-20
Last Posted Date
2014-08-20
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
96
Registration Number
NCT02221401

A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

Phase 2
Completed
Conditions
Diabetes
Diabetes Mellitus Type 2
Interventions
Drug: Metformin
Drug: Liraglutide
Drug: Placebo
Drug: NNC0090-2746
First Posted Date
2014-07-31
Last Posted Date
2020-07-21
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
108
Registration Number
NCT02205528
Locations
🇺🇸

Novo Nordisk Investigational Site, Manassas, Virginia, United States

A Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2330672 Administered With Metformin to Type 2 Diabetes Patients

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: GSK2330672
Drug: Placebo
Drug: Sitagliptin
Drug: Metformin
First Posted Date
2014-07-28
Last Posted Date
2017-11-06
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
70
Registration Number
NCT02202161
Locations
🇺🇸

GSK Investigational Site, San Antonio, Texas, United States

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