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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
-

Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer

Phase 2
Active, not recruiting
Conditions
Colorectal Cancer Metastatic
Colorectal Adenocarcinoma
Metastatic Microsatellite Stable Colorectal Carcinoma
Refractory Colorectal Carcinoma
Stage IV Colorectal Cancer
Stage IVA Colorectal Cancer
Stage IVB Colorectal Cancer
Stage IVC Colorectal Cancer
Interventions
First Posted Date
2019-01-11
Last Posted Date
2023-07-05
Lead Sponsor
Emory University
Target Recruit Count
24
Registration Number
NCT03800602
Locations
🇺🇸

Emory University Hospital Midtown, Atlanta, Georgia, United States

🇺🇸

Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, United States

🇺🇸

Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

Comparison of the Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Ratio Combination to Insulin Glargine in Patients With Type 2 Diabetes Insufficiently Controlled on Basal Insulin

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)
Drug: Insulin glargine (HOE901)
Drug: Metformin
First Posted Date
2019-01-09
Last Posted Date
2022-07-19
Lead Sponsor
Sanofi
Target Recruit Count
426
Registration Number
NCT03798080
Locations
🇨🇳

Investigational Site Number 1560054, Changchun, China

🇨🇳

Investigational Site Number 1560005, Changchun, China

🇨🇳

Investigational Site Number 1560025, Fuzhou, China

and more 42 locations

Evaluation of Insulin Glargine/Lixisenatide Fixed Ratio Combination in Patients With Type 2 Diabetes Insufficiently Controlled With Oral Antidiabetic Drug(s)

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Lixisenatide (AVE0010)
Drug: Insulin glargine/Lixisenatide (HOE901/AVE0010)
Drug: Insulin glargine (HOE901)
Drug: Metformin
Drug: SGLT2 inhibitor
First Posted Date
2019-01-09
Last Posted Date
2022-07-19
Lead Sponsor
Sanofi
Target Recruit Count
878
Registration Number
NCT03798054
Locations
🇨🇳

Investigational Site Number 1560013, Shanghai, China

🇨🇳

Investigational Site Number 1560004, Shanghai, China

🇨🇳

Investigational Site Number 1560029, Shanghai, China

and more 76 locations

Study of PF 04965842 Effect on MATE1/2K Activity in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2019-01-08
Last Posted Date
2020-02-05
Lead Sponsor
Pfizer
Target Recruit Count
12
Registration Number
NCT03796182
Locations
🇧🇪

Pfizer Clinical Research Unit, Brussels, Belgium

Efficacy and Safety of Alogliptin vs. Acarbose in Chinese Type 2 Diabetes Mellitus (T2DM) Patients With High CV Risk or CHD Treated With Aspirin and Inadequately Controlled With Metformin Monotherapy or Drug Naive

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2019-01-07
Last Posted Date
2022-04-25
Lead Sponsor
Sanofi
Target Recruit Count
1293
Registration Number
NCT03794336
Locations
🇨🇳

CHINA, China, China

The Effect of Calcium and Vitamin D Supplements on Metabolic and Hormonal Disturbances in Polycystic Ovary Syndrome Patients

Phase 3
Completed
Conditions
Polycystic Ovary Syndrome
Vitamin D Deficiency/Insufficiency
Interventions
Dietary Supplement: Vitamin D3
Drug: Metformin
Drug: Placebo
Dietary Supplement: Calcium Carbonate
First Posted Date
2019-01-04
Last Posted Date
2019-06-06
Lead Sponsor
Damascus University
Target Recruit Count
40
Registration Number
NCT03792984
Locations
🇸🇾

Damascus University of Obstetrics and Gynecology Hospital, Damascus, Syrian Arab Republic

🇸🇾

Orient Hospital, Damascus, Syrian Arab Republic

Assessing Goldenseal-drug Interactions Using a Probe Drug Cocktail Approach

Early Phase 1
Completed
Conditions
Interaction Drug Food
Interventions
Dietary Supplement: goldenseal
Drug: Metformin
Drug: Furosemide
Drug: Midazolam oral solution
Drug: Rosuvastatin Oral Tablet
First Posted Date
2018-12-11
Last Posted Date
2023-04-28
Lead Sponsor
Washington State University
Target Recruit Count
16
Registration Number
NCT03772262
Locations
🇺🇸

Washington State University, Spokane, Washington, United States

Metformin vs Tolvaptan for Treatment of Autosomal Dominant Polycystic Kidney Disease

Phase 3
Conditions
ADPKD
Interventions
First Posted Date
2018-12-05
Last Posted Date
2018-12-07
Lead Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Target Recruit Count
150
Registration Number
NCT03764605
Locations
🇮🇹

AOUC "Policlinico", Bari, Italy

🇮🇹

AOUConsorziale Policlinico Di Bari, Bari, Italy

Efficacy and Safety of Sotagliflozin Versus Placebo in Chinese Patients With Type 2 Diabetes Mellitus Not Adequately Controlled by Metformin With or Without Sulfonylurea

Phase 3
Terminated
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: sotagliflozin (SAR439954)
Drug: placebo
Drug: metformin
Drug: sulfonylurea
First Posted Date
2018-12-03
Last Posted Date
2022-04-25
Lead Sponsor
Sanofi
Target Recruit Count
377
Registration Number
NCT03761134
Locations
🇨🇳

Investigational Site Number 1560039, Baotou, China

🇨🇳

Investigational Site Number 1560028, Dalian, China

🇨🇳

Investigational Site Number 1560040, Baotou, China

and more 37 locations

A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes.

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo (insulin 287)
Drug: Insulin icodec
Drug: Metformin
Drug: Dipeptidyl peptidase-4 inhibitors
Drug: Placebo (insulin glargine)
Drug: Insulin glargine
First Posted Date
2018-11-23
Last Posted Date
2021-04-02
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
247
Registration Number
NCT03751657
Locations
🇸🇮

Novo Nordisk Investigational Site, Ljubljana, Slovenia

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