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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 Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fasting Conditions.

Phase 1
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2010-03-18
Last Posted Date
2010-10-14
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT01089192
Locations
🇮🇳

Torrent Research Centre, Bhat, Gujarat, India

Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.

Phase 1
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2010-03-18
Last Posted Date
2010-07-29
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT01089205

Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 mg Tablet in Healthy Volunteers Under Fed Conditions

Phase 1
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2010-03-18
Last Posted Date
2010-05-07
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT01089179
Locations
🇮🇳

Torrent Research Centre, Bhat, Gujarat, India

Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition

Phase 1
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2010-03-18
Last Posted Date
2010-06-22
Lead Sponsor
Torrent Pharmaceuticals Limited
Registration Number
NCT01089166
Locations
🇮🇳

Torrent Research Centre, Bhat, Gujarat, India

Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus

Phase 2
Completed
Conditions
Gestational Diabetes Mellitus
Interventions
Drug: Metformin
Drug: Insulin
First Posted Date
2010-03-16
Last Posted Date
2010-03-16
Lead Sponsor
University of Oulu
Target Recruit Count
97
Registration Number
NCT01087866
Locations
🇫🇮

Oulu University Hospital, Oulu, Finland

Lapatinib With Sirolimus or Metformin

Phase 1
Completed
Conditions
Advanced Cancers
Interventions
First Posted Date
2010-03-16
Last Posted Date
2015-11-11
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
111
Registration Number
NCT01087983
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Effect of Treatment With Insulin Sensitizer on Arterial Properties, Metabolic Parameters and Liver Function in Patients With Nonalcoholic Fatty Liver Disease

Phase 1
Completed
Conditions
Nonalcoholic Fatty Liver Disease
Interventions
First Posted Date
2010-03-10
Last Posted Date
2010-03-10
Lead Sponsor
Wolfson Medical Center
Registration Number
NCT01084486
Locations
🇮🇱

Wolfson Medical Center, Holon, Israel

Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome

Phase 2
Completed
Conditions
Metabolic Syndrome
Hypercholesterolemia
Interventions
First Posted Date
2010-03-01
Last Posted Date
2014-05-15
Lead Sponsor
Western Sydney Local Health District
Target Recruit Count
28
Registration Number
NCT01077479
Locations
🇦🇺

Westmead Hospital, Sydney, New South Wales, Australia

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-02-25
Last Posted Date
2015-01-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
810
Registration Number
NCT01075282
Locations
🇨🇳

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., Yung-Kang, Tainan, Taiwan

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