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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 to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects

Phase 1
Completed
Conditions
Heathy Volunteer
Interventions
First Posted Date
2017-12-06
Last Posted Date
2019-01-25
Lead Sponsor
Celgene
Target Recruit Count
56
Registration Number
NCT03363815
Locations
🇺🇸

Covance Clinical Research Unit, Daytona Beach, Florida, United States

Pharmacokinetics of Metformin Intolerance

Phase 4
Completed
Conditions
Diabetes Mellitus, Type 2
Metformin Adverse Reaction
Interventions
First Posted Date
2017-12-05
Last Posted Date
2017-12-05
Lead Sponsor
NHS Tayside
Target Recruit Count
20
Registration Number
NCT03361878

Comparison of Two Treatment Regimens in Patients With Type 2 Diabetes After Short-term Intensive Insulin Therapy

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2017-12-02
Last Posted Date
2022-04-25
Lead Sponsor
Sanofi
Target Recruit Count
384
Registration Number
NCT03359837
Locations
🇨🇳

CHINA, China, China

Metformin Treatment for Colon Cancer

Phase 2
Completed
Conditions
Colon Cancer
Interventions
Drug: Placebo oral capsule
Drug: Metformin Hydrochloride
First Posted Date
2017-12-02
Last Posted Date
2022-03-03
Lead Sponsor
Zealand University Hospital
Target Recruit Count
48
Registration Number
NCT03359681
Locations
🇩🇰

Department of Surgery, Slagelse Hospital, Slagelse, Denmark

Research of Exenatide for Overweight/Obese PCOS Patients With IGR

Phase 4
Completed
Conditions
Overweight and Obesity
Disorder of Glucose Regulation
Polycystic Ovary Syndrome
Interventions
First Posted Date
2017-11-24
Last Posted Date
2019-09-11
Lead Sponsor
RenJi Hospital
Target Recruit Count
183
Registration Number
NCT03352869
Locations
🇨🇳

Renji Hospital Department of Endocrinology and Metabolism, Shanghai, China

Cardiometabolic Disease and Pulmonary Hypertension

Early Phase 1
Terminated
Conditions
Obesity
Interventions
Drug: Placebo
Drug: Metformin
First Posted Date
2017-11-22
Last Posted Date
2022-01-21
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
21
Registration Number
NCT03349775
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Loose-dose Combination of Acarbose and Metformin for T2DM in Metformin-failure Patients

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2017-11-21
Last Posted Date
2020-08-05
Lead Sponsor
Bayer
Target Recruit Count
287
Registration Number
NCT03349684
Locations
🇨🇳

The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China

🇨🇳

Anhui Provincial Hospital, Hefei, Anhui, China

🇨🇳

Sun Yat-Sen Memorial Hosp. Sun Yat-Sen Univ., Guangzhou, Guangdong, China

and more 26 locations

Metformin in Heart Failure Without Diabetes

Phase 2
Terminated
Conditions
Heart Failure
Interventions
First Posted Date
2017-11-06
Last Posted Date
2024-07-18
Lead Sponsor
Columbia University
Target Recruit Count
6
Registration Number
NCT03331861
Locations
🇺🇸

New York Hospital - Columbia University Irving Medical Center, New York, New York, United States

Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2017-11-06
Last Posted Date
2021-05-11
Lead Sponsor
Lexicon Pharmaceuticals
Target Recruit Count
954
Registration Number
NCT03332771
Locations
🇺🇸

Investigational Site Number 8407074, Bradenton, Florida, United States

🇺🇸

Investigational Site Number 8407111, Dallas, Texas, United States

🇺🇸

Investigational Site Number 8407078, Carmichael, California, United States

and more 139 locations

Comparison of Metformin and Insulin for Management of Gestational Diabetes Mellitus

Phase 3
Completed
Conditions
Gestational Diabetes Mellitus in Pregnancy
Interventions
Drug: Insulin
Drug: Metformin
First Posted Date
2017-10-25
Last Posted Date
2017-10-27
Lead Sponsor
Services Institute of Medical Sciences, Pakistan
Target Recruit Count
278
Registration Number
NCT03320694
Locations
🇵🇰

Services Institute of Medical Sciences, Lahore, Punjab, Pakistan

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