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: C_₄H_₁₁N_₅

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: -

Clinical Trials

Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study

Phase 2

Completed

Conditions: Polycystic Ovary Syndrome

Interventions: Drug: Placebo
Drug: Metformin

First Posted Date: 2017-08-24

Last Posted Date: 2018-10-18

Lead Sponsor: Norwegian University of Science and Technology

Target Recruit Count: 40

Registration Number: NCT03259919

Locations: 🇳🇴
Departments of Obstetrics and Gynecology and Endocrinology, St. Olav's Hospital, Trondheim, Norway

Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

Phase 4

Terminated

Conditions: Diabetes

Interventions: Behavioral: Lifestyle Intervention
Drug: Metformin

First Posted Date: 2017-08-23

Last Posted Date: 2024-02-06

Lead Sponsor: Yale University

Target Recruit Count: 114

Registration Number: NCT03258723

Locations: 🇻🇮
Ministry of Health Clinics, Charlotte Amalie, Virgin Islands (U.S.)
🇹🇹
Southwest Regional Health Authority, La Romaine Health Center, San Fernando, Trinidad and Tobago
🇧🇧
University of the West Indies, Cavehill and Barbados Ministry of Health Polyclinics, Bridgetown, Barbados

and more 1 locations

This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Empagliflozin/linagliptin/metformin HCl
Drug: Empagliflozin
Drug: Linagliptin
Drug: Metformin HCl

First Posted Date: 2017-08-23

Last Posted Date: 2020-03-05

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 30

Registration Number: NCT03259490

Locations: 🇩🇪
Humanpharmakologisches Zentrum Biberach, Biberach, Germany

The Role of GLP-1 Receptor Signalling in the Glucose-lowering Effect of Metformin in Patients With T2D

Not Applicable

Completed

Conditions: Glucose Metabolism Disorders

Interventions: Drug: Placebo Oral Tablet
Drug: Saline
Drug: Metformin
Drug: Exendin (9-39)

First Posted Date: 2017-08-11

Last Posted Date: 2018-07-09

Lead Sponsor: University Hospital, Gentofte, Copenhagen

Target Recruit Count: 15

Registration Number: NCT03246451

Locations: 🇩🇰
Center for Diabetes Research, Gentofte, Copenhagen, Denmark

Randomized Trial of Neo-adjuvant Chemotherapy With or Without Metformin for HER2 Positive Operable Breast Cancer

Phase 2

Conditions: HER2-positive Breast Cancer

Interventions: Drug: Taxotere, Carboplatin, Herceptin + Pertuzumab
Drug: Metformin

First Posted Date: 2017-08-03

Last Posted Date: 2021-12-07

Lead Sponsor: Qamar Khan

Target Recruit Count: 100

Registration Number: NCT03238495

Locations: 🇺🇸
The University of Kansas Cancer Center, Westwood Campus, Kansas City, Kansas, United States
🇺🇸
The University of Kansas Cancer Center, West Clinic, Kansas City, Kansas, United States
🇺🇸
The University of Kansas Cancer Center, Overland Park Clinic, Overland Park, Kansas, United States

and more 3 locations

OCP vs Metformin on Ovarian Stromal Blood Flow in PCOS

Phase 4

Completed

Conditions: PCOS

Interventions: Drug: Ethinyl Estradiol-cyprosterone acetate
Drug: Metformin Hydrochloride

First Posted Date: 2017-08-02

Last Posted Date: 2018-03-20

Lead Sponsor: S.C.B. Medical College and Hospital

Target Recruit Count: 101

Registration Number: NCT03236740

Locations: 🇮🇳
SCB Medical College, Cuttack, Orissa, India

A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: LY900014
Drug: Insulin Lispro
Drug: Insulin Glargine
Drug: Insulin Degludec
Drug: Metformin
Drug: SGLT2 inhibitor

First Posted Date: 2017-07-11

Last Posted Date: 2020-03-27

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 933

Registration Number: NCT03214380

Locations: 🇺🇸
Rocky Mountain Diabetes and Osteoporosis Center, Idaho Falls, Idaho, United States
🇺🇸
Aventiv Research, Columbus, Ohio, United States
🇺🇸
Dallas Diabetes Endocrine Center, Dallas, Texas, United States

and more 37 locations

Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis

Phase 2

Completed

Conditions: Chronic Periodontitis

Interventions: Drug: Aloevera
Drug: placebo gel
Drug: Metformin

First Posted Date: 2017-06-29

Last Posted Date: 2017-06-29

Lead Sponsor: Government Dental College and Research Institute, Bangalore

Target Recruit Count: 90

Registration Number: NCT03204071

Locally Delivered Metformin & Rosuvastatin for Treatment of Intrabony Defects in Chronic Periodontitis

Phase 2

Completed

Conditions: Chronic Periodontitis

Interventions: Drug: Placebos
Drug: Rosuvastatin
Drug: Metformin

First Posted Date: 2017-06-29

Last Posted Date: 2017-06-29

Lead Sponsor: Government Dental College and Research Institute, Bangalore

Target Recruit Count: 90

Registration Number: NCT03204058

Trial to Evaluate the Efficacy on Glycemic Variability and Safety of Gemigliptin Compared With Dapagliflozin Added on Metformin Alone or Diabetes Medication Naïve Patient in Type 2 Diabetes Mellitus (Stable II Study)

Phase 4

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Gemigliptin 50mg
Drug: Dapagliflozin 10mg
Procedure: Diet/exercise questionnaire
Device: Continuous Glucose Monitoring System(CGMS)
Drug: Metformin

First Posted Date: 2017-06-28

Last Posted Date: 2019-02-15

Lead Sponsor: LG Chem

Target Recruit Count: 71

Registration Number: NCT03202563

Locations: 🇰🇷
Samsung Medical Center, Seoul, Korea, Republic of

Drug Development Updates

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