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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
-

Early Intervention for Gestational Diabetes

Not Applicable
Withdrawn
Conditions
Gestational Diabetes Mellitus
Interventions
Drug: Placebo
Drug: Metformin
First Posted Date
2010-07-28
Last Posted Date
2013-01-16
Lead Sponsor
Intermountain Health Care, Inc.
Registration Number
NCT01171456
Locations
🇺🇸

Intermountain Medical Center, Murray, Utah, United States

Efficacy and Safety of Lixisenatide in Patients With Type 2 Diabetes Mellitus Insufficiently Controlled by Metformin

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Lixisenatide (AVE0010)
Drug: Placebo
Device: Pen auto-injector
Drug: Metformin
Drug: Sulfonylurea
First Posted Date
2010-07-26
Last Posted Date
2016-10-13
Lead Sponsor
Sanofi
Target Recruit Count
391
Registration Number
NCT01169779
Locations
🇨🇳

Investigational Site Number 156009, Beijing, China

🇨🇳

Investigational Site Number 156016, Changsha, China

🇨🇳

Investigational Site Number 156015, Changsha, China

and more 32 locations

Combination Chemotherapy With or Without Metformin Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer

Phase 2
Terminated
Conditions
Pancreatic Cancer
Interventions
First Posted Date
2010-07-22
Last Posted Date
2015-04-24
Lead Sponsor
IRCCS San Raffaele
Target Recruit Count
60
Registration Number
NCT01167738
Locations
🇮🇹

Istituto Scientifico H. San Raffaele, Milan, Italy

Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fasting Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-07-12
Last Posted Date
2010-07-26
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
54
Registration Number
NCT01160042
Locations
🇮🇳

Vimta Labs Ltd., Hyderabad, Andhra pradesh, India

Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fed Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-07-12
Last Posted Date
2010-07-13
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
50
Registration Number
NCT01160068
Locations
🇮🇳

Vimta Labs Ltd., Hyderabad, Andhra pradesh, India

The CANTATA-D2 Trial (CANagliflozin Treatment And Trial Analysis - DPP-4 Inhibitor Second Comparator Trial)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-06-04
Last Posted Date
2015-01-15
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
756
Registration Number
NCT01137812

A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2010-06-02
Last Posted Date
2024-11-11
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
168
Registration Number
NCT01135433

Study of Sitagliptin Treatment in Patients With Type 2 Diabetes During Ramadan (0431-263)

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus (T2DM)
Interventions
First Posted Date
2010-05-26
Last Posted Date
2022-09-21
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
1147
Registration Number
NCT01131182

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: LY2189265
Drug: Metformin
Drug: Placebo (oral)
Drug: Placebo (subcutaneous)
First Posted Date
2010-05-19
Last Posted Date
2015-01-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
807
Registration Number
NCT01126580
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., Nottingham, United Kingdom

Spectroscopic and Colorimetric Analysis of Acanthosis Nigricans in Patients With Hyperinsulinemia

Completed
Conditions
Acanthosis Nigricans
Hyperinsulinemia
Spectroscopic Analysis
First Posted Date
2010-05-18
Last Posted Date
2012-09-06
Lead Sponsor
Henry Ford Health System
Target Recruit Count
9
Registration Number
NCT01125150
Locations
🇺🇸

Department of Dermatology, NEW CENTER ONE, Detroit, Michigan, United States

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