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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 Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2014-04-22
Last Posted Date
2021-05-27
Lead Sponsor
OPKO Health, Inc.
Target Recruit Count
420
Registration Number
NCT02119819
Locations
🇺🇸

Southern New Hampshire Diabetes and Endocrinology, Nashua, New Hampshire, United States

🇷🇴

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., Timisoara, Romania

🇵🇷

Manati Medical Center, Manati, Puerto Rico

and more 31 locations

A Study of LY2409021 in Participants With Type 2 Diabetes Mellitus

Phase 2
Terminated
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: LY2409021
Drug: Placebo
Drug: Sitagliptin
Drug: Metformin
Drug: Sulfonylurea
First Posted Date
2014-04-10
Last Posted Date
2019-10-09
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
174
Registration Number
NCT02111096
Locations
🇺🇸

Midwest CRC, Crystal Lake, Illinois, United States

🇺🇸

Iderc, P.L.C., Des Moines, Iowa, United States

🇺🇸

Cotton O'Neil Clinic, Topeka, Kansas, United States

and more 27 locations

Relative Bioavailability of Multiple Oral Doses of BI 187004 and Metformin After Co-administration Compared to Multiple Oral Doses of BI 187004 Alone and Metformin Alone in Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: BI 187004
Drug: metformin
First Posted Date
2014-04-10
Last Posted Date
2016-01-27
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
16
Registration Number
NCT02109679
Locations
🇩🇪

1307.7.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

A Study of LY2409021 on Blood Pressure and Pulse Rate in Participants With Type 2 Diabetes Mellitus

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Drug: LY2409021
Drug: Metformin
First Posted Date
2014-03-19
Last Posted Date
2018-07-19
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
270
Registration Number
NCT02091362
Locations
🇺🇸

University Clinical Investigators, Inc., Tustin, California, United States

🇺🇸

Cedar-Crosse Research Center, Chicago, Illinois, United States

🇺🇸

National Research Institute, Los Angeles, California, United States

and more 15 locations

Oral Antidiabetic Agents in Pregnancy

Phase 4
Conditions
Gestational Diabetes
Interventions
First Posted Date
2014-03-19
Last Posted Date
2014-03-19
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Target Recruit Count
80
Registration Number
NCT02091336
Locations
🇧🇷

Hospital de Clínicas de Porto Alegre, Porto Alegre, RS, Brazil

A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Nateglinide/Metformin
Drug: Nateglinide
Drug: Metformin
First Posted Date
2014-03-17
Last Posted Date
2014-03-17
Lead Sponsor
IlDong Pharmaceutical Co Ltd
Target Recruit Count
40
Registration Number
NCT02088918
Locations
🇰🇷

Chungnam University Hospital, Daejeon, Korea, Republic of

Study of Clinical Response to Acute Metformin by Leveraging Evaluations During a Mixed Meal Tolerance Test for Exploring Glycemia and GeneticS

Not Applicable
Active, not recruiting
Conditions
Genetics
Metabolism
Type 2 Diabetes
Interventions
Other: Mixed Meal Tolerance Test
Drug: Metformin
First Posted Date
2014-03-14
Last Posted Date
2024-11-22
Lead Sponsor
Massachusetts General Hospital
Target Recruit Count
1017
Registration Number
NCT02087826
Locations
🇺🇸

Massachusetts General Hospital, Boston, Massachusetts, United States

Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)

Phase 1
Completed
Conditions
Polycystic Ovary Syndrome
Interventions
First Posted Date
2014-03-13
Last Posted Date
2018-03-19
Lead Sponsor
Mayo Clinic
Target Recruit Count
68
Registration Number
NCT02086526
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

Pilot Study of Metformin in Head and Neck Squamous Cell Cancer and Its Effects on Stromal-epithelial Metabolic Uncoupling

Early Phase 1
Completed
Conditions
Head and Neck Squamous Cell Cancer
Interventions
First Posted Date
2014-03-11
Last Posted Date
2024-02-22
Lead Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
Target Recruit Count
50
Registration Number
NCT02083692
Locations
🇺🇸

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Bioequivalence of a FDC Tablet of Linagliptin/Metformin (2.5mg/1000mg) Extended Release in Healthy Subjects.

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Linagliptin
Drug: Metformin
Drug: Linagliptin/Metformin FDC
First Posted Date
2014-03-11
Last Posted Date
2016-08-04
Lead Sponsor
Boehringer Ingelheim
Target Recruit Count
74
Registration Number
NCT02084056
Locations
🇩🇪

1288.11.1 Boehringer Ingelheim Investigational Site, Biberach, Germany

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