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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
-

Bioequivalence and Drug - Drug Interaction Study of Metformin/Gliclazide in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Metformin/Gliclazide Fixed Combination
Drug: Metformin
Drug: Gliclazide
First Posted Date
2018-03-16
Last Posted Date
2019-07-16
Lead Sponsor
Merck KGaA, Darmstadt, Germany
Target Recruit Count
40
Registration Number
NCT03467945
Locations
🇩🇪

Please Contact the Merck KGaA Communication Center, Darmstadt, Germany

Study of Metformin Plus Oligomeric Procyanidin Complex for Pharmacologic Manipulation of AGE (Advanced Glycation Endproducts) Levels in Prostate Cancer Patients

Phase 1
Withdrawn
Conditions
Prostate Cancer
Interventions
Drug: Metformin
Drug: Oligomeric Procyanidin Complex
First Posted Date
2018-03-14
Last Posted Date
2018-08-03
Lead Sponsor
Medical University of South Carolina
Registration Number
NCT03465345
Locations
🇺🇸

Medical University of South Carolina, Charleston, South Carolina, United States

Bioequivalence Study of Metformin 1000 mg Tablets Immediate Release (IR) Versus Glucophage® 1000 mg Tablets IR In Healthy Subjects

Phase 1
Completed
Conditions
Bioequivalence
Interventions
First Posted Date
2018-03-08
Last Posted Date
2018-07-03
Lead Sponsor
Geropharm
Target Recruit Count
18
Registration Number
NCT03458208
Locations
🇷🇺

Yarosslavl Clinical Hospital #3, Yaroslavl, Russian Federation

Insulin Signaling in Skeletal Muscle

Phase 2
Withdrawn
Conditions
Insulin Sensitivity
Interventions
First Posted Date
2018-03-02
Last Posted Date
2020-10-08
Lead Sponsor
Wayne State University
Registration Number
NCT03452267

Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions

Phase 1
Completed
Conditions
Bioequivalence
Interventions
First Posted Date
2018-03-02
Last Posted Date
2018-07-03
Lead Sponsor
Geropharm
Target Recruit Count
28
Registration Number
NCT03452306
Locations
🇷🇺

Yarosslavl Clinical Hospital #3, Yaroslavl, Russian Federation

Effect of Metformin on Frailty in 12 Subjects

Phase 2
Terminated
Conditions
Aging
Inflammation
Frailty
Interventions
Drug: Placebo
Drug: Metformin
First Posted Date
2018-03-01
Last Posted Date
2022-11-17
Lead Sponsor
Mayo Clinic
Target Recruit Count
7
Registration Number
NCT03451006
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Metformin Gastrointestinal Intolerance: Measurement of Mitochondrial Complex I

Early Phase 1
Completed
Conditions
Diabetes Mellitus, Type 2
Metformin Adverse Reaction
Interventions
Drug: Placebo
Drug: Metformin
First Posted Date
2018-02-26
Last Posted Date
2020-10-28
Lead Sponsor
St. Louis University
Target Recruit Count
15
Registration Number
NCT03445702
Locations
🇺🇸

Saint Louis University, Saint Louis, Missouri, United States

Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Drug: MEDI0382
Drug: Dapaglifozin
Drug: Metformin
First Posted Date
2018-02-23
Last Posted Date
2020-01-13
Lead Sponsor
MedImmune LLC
Target Recruit Count
49
Registration Number
NCT03444584
Locations
🇬🇧

Research Site, Rotherham, United Kingdom

Efficacy of Metformin in Preventing Diabetes in China

Phase 4
Completed
Conditions
PreDiabetes
Interventions
Other: Standard lifestyle intervention
Drug: metformin
First Posted Date
2018-02-22
Last Posted Date
2021-11-15
Lead Sponsor
Chinese Association of Geriatric Research
Target Recruit Count
1724
Registration Number
NCT03441750
Locations
🇨🇳

The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO)TM

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2018-02-12
Last Posted Date
2024-02-23
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
175
Registration Number
NCT03429543
Locations
🇺🇸

Children's Center for Advanced Pediatrics, Atlanta, Georgia, United States

🇺🇸

Atlanta Center, Atlanta, Georgia, United States

🇺🇸

Stanford University Medical Center, Palo Alto, California, United States

and more 79 locations
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