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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 and Safety of Biphasic Insulin Aspart 30 in Combination With Metformin in Type 2 Diabetes

Phase 4
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
First Posted Date
2008-02-21
Last Posted Date
2017-01-06
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
260
Registration Number
NCT00619697
Locations
🇸🇮

Novo Nordisk Investigational Site, Maribor, Slovenia

Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine

Phase 2
Terminated
Conditions
Weight Gain
Interventions
Drug: metformin
Behavioral: healthy lifestyle intervention
First Posted Date
2008-02-15
Last Posted Date
2012-12-31
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
1
Registration Number
NCT00617058
Locations
🇺🇸

University of North Carolina, Department of Psychiatry, Chapel HIll, North Carolina, United States

Strategies to Reduce Antipsychotic-Associated Weight Gain in Youth

Phase 2
Completed
Conditions
Weight Gain
Interventions
Drug: metformin
Drug: placebo
First Posted Date
2008-02-15
Last Posted Date
2014-03-11
Lead Sponsor
University of North Carolina, Chapel Hill
Target Recruit Count
9
Registration Number
NCT00617240
Locations
🇺🇸

University of North Carolina, Department of Psychiatry, Chapel Hill, North Carolina, United States

Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

Phase 2
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-02-13
Last Posted Date
2017-03-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
178
Registration Number
NCT00614055
Locations
🇪🇸

Novo Nordisk Investigational Site, Valladolid, Spain

Comparison of Two NN5401 Formulations Versus Biphasic Insulin Aspart 30, All in Combination With Metformin in Subjects With Type 2 Diabetes

Phase 2
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-02-13
Last Posted Date
2017-03-20
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
182
Registration Number
NCT00613951
Locations
🇪🇸

Novo Nordisk Investigational Site, San Juan, Spain

Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

Phase 3
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-02-13
Last Posted Date
2017-03-08
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
929
Registration Number
NCT00614120
Locations
🇰🇷

Novo Nordisk Investigational Site, Suwon, Korea, Republic of

Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Glimepiride/metformin fixed combination
Drug: Metformin HCl
First Posted Date
2008-02-11
Last Posted Date
2013-03-28
Lead Sponsor
Handok Inc.
Target Recruit Count
192
Registration Number
NCT00612144
Locations
🇰🇷

Handok Pharmaceuticals, Co., LTD, Seoul, Korea, Republic of

Comparison of Two NN1250 Formulations Versus Insulin Glargine, All in Combination With Metformin in Subjects With Type 2 Diabetes

Phase 2
Completed
Conditions
Diabetes
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2008-02-11
Last Posted Date
2017-03-03
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
245
Registration Number
NCT00611884
Locations
🇿🇦

Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, South Africa

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes

Phase 2
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
First Posted Date
2008-01-31
Last Posted Date
2012-02-13
Lead Sponsor
Novartis
Target Recruit Count
231
Registration Number
NCT00605475
Locations
🇺🇸

Allied Research International - Cetero Research Miami, Miami, Florida, United States

🇺🇸

Elite Research Institute Miami, Miami, Florida, United States

🇷🇺

Novartis Investigative Site, St. Petersberg, Russian Federation

and more 5 locations

Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Diabetes
First Posted Date
2008-01-23
Last Posted Date
2017-01-09
Lead Sponsor
Novo Nordisk A/S
Target Recruit Count
242
Registration Number
NCT00598793
Locations
🇺🇸

Novo Nordisk Investigational Site, Renton, Washington, United States

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