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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
-

Efficacy of Pioglitazone in Participants With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy

Phase 4
Completed
Conditions
Type II Diabetes Mellitus
Interventions
First Posted Date
2013-10-30
Last Posted Date
2018-09-12
Lead Sponsor
Takeda
Target Recruit Count
114
Registration Number
NCT01972724

Treatment of Patients With Advanced Pancreatic Cancer After Gemcitabine Failure.

Phase 2
Completed
Conditions
Pancreatic Adenocarcinoma Advanced or Metastatic
Interventions
First Posted Date
2013-10-28
Last Posted Date
2014-05-16
Lead Sponsor
Instituto do Cancer do Estado de São Paulo
Target Recruit Count
41
Registration Number
NCT01971034
Locations
🇧🇷

ICESP, Sao Paulo, SP, Brazil

The Effect of Simple Basal Insulin Titration, Metformin Plus Liraglutide for Type 2 Diabetes With Very Elevated HbA1c - The SIMPLE Study

Phase 4
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2013-10-22
Last Posted Date
2019-10-22
Lead Sponsor
University of Texas Southwestern Medical Center
Target Recruit Count
157
Registration Number
NCT01966978
Locations
🇺🇸

UT Southwestern Medical Center, Dallas, Texas, United States

Effect of Insulin Sensitizer Metformin on AD Biomarkers

Phase 2
Completed
Conditions
Alzheimer's Disease
Vascular Dementia
Dementia
Memory Impairment
Interventions
Drug: Metformin
Drug: Placebos
First Posted Date
2013-10-18
Last Posted Date
2017-09-21
Lead Sponsor
University of Pennsylvania
Target Recruit Count
20
Registration Number
NCT01965756
Locations
🇺🇸

University of Pennsylvania, Penn Memory Center, Philadelphia, Pennsylvania, United States

Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients

Not Applicable
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2013-10-16
Last Posted Date
2013-10-16
Lead Sponsor
Tehran University of Medical Sciences
Target Recruit Count
84
Registration Number
NCT01963663
Locations
🇮🇷

Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran, Islamic Republic of

Study to Assess the Dietary Carbohydrate Content of Indian Diabetics With Special Therapeutic View on Effectiveness of Acarbose and Metformin Monotherapy

Withdrawn
Conditions
Diabetes Mellitus
Interventions
Drug: Bay G5421 Glucobay
Drug: Metformin
First Posted Date
2013-10-11
Last Posted Date
2016-06-15
Lead Sponsor
Bayer
Registration Number
NCT01961388

Effect of Saxagliptin on Pre-Diabetes Mellitus and Obesity

Phase 4
Conditions
Prediabetes
Interventions
Other: lifestyle intervention
Drug: metformin
Drug: saxagliptin
First Posted Date
2013-10-10
Last Posted Date
2014-09-25
Lead Sponsor
Shandong Provincial Hospital
Target Recruit Count
80
Registration Number
NCT01960205
Locations
🇨🇳

Shandong Provincial Hospital, Jinan, Shandong, China

Randomized, Placebo-controlled, 2 Period, Single-blind, Sequential, Multiple Ascending Dose Study

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: DS-7309
Drug: placebo
Drug: Metformin
First Posted Date
2013-10-08
Last Posted Date
2014-11-24
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
48
Registration Number
NCT01956305
Locations
🇺🇸

Worldwide Clinical Trials, San Antonio, Texas, United States

Metformin's Effect on Glucagon-induced Glucose Production and Protein Metabolism.

Phase 1
Completed
Conditions
Prediabetic State
Insulin Resistance
Interventions
Drug: Placebo
Drug: Metformin
First Posted Date
2013-10-08
Last Posted Date
2017-09-01
Lead Sponsor
Mayo Clinic
Target Recruit Count
12
Registration Number
NCT01956929
Locations
🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

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