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
- -
The CANTATA-MSU Trial (CANagliflozin Treatment And Trial Analysis - Metformin and SUlphonylurea)
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- First Posted Date
- 2010-04-20
- Last Posted Date
- 2013-06-20
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 469
- Registration Number
- NCT01106625
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
- First Posted Date
- 2010-04-12
- Last Posted Date
- 2023-09-13
- Lead Sponsor
- Canadian Cancer Trials Group
- Target Recruit Count
- 3649
- Registration Number
- NCT01101438
- Locations
- 🇺🇸
Kaiser Permanente-San Rafael, San Rafael, California, United States
🇨🇦The Vitalite Health Network - Dr. Leon Richard, Moncton, New Brunswick, Canada
🇺🇸Kaiser Permanente-Vallejo, Vallejo, California, United States
Ketosis-Prone Diabetes Mellitus (KPDM): Metformin Versus Sitagliptin Treatment
- Conditions
- Diabetes KetoacidosisHyperglycemiaKetosis Prone Diabetes
- Interventions
- First Posted Date
- 2010-04-07
- Last Posted Date
- 2015-06-18
- Lead Sponsor
- Dawn Smiley MD
- Target Recruit Count
- 48
- Registration Number
- NCT01099618
- Locations
- 🇺🇸
Grady Memorial Hospital, Atlanta, Georgia, United States
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled With Diet and Exercise
- Conditions
- Type 2 Diabetes
- Interventions
- First Posted Date
- 2010-03-30
- Last Posted Date
- 2017-02-06
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1179
- Registration Number
- NCT01095653
- Locations
- 🇨🇳
Local Institution, Yung Kang city, Taiwan
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
- Conditions
- Type 2 Diabetes
- Interventions
- First Posted Date
- 2010-03-30
- Last Posted Date
- 2017-09-11
- Lead Sponsor
- AstraZeneca
- Target Recruit Count
- 1484
- Registration Number
- NCT01095666
- Locations
- 🇰🇷
Local Institution, Seoul, Korea, Republic of
Renal and Hormonal Effects of Pioglitazone
- First Posted Date
- 2010-03-22
- Last Posted Date
- 2010-04-08
- Lead Sponsor
- University Hospital, Geneva
- Target Recruit Count
- 16
- Registration Number
- NCT01090752
- Locations
- 🇨🇭
Pechère-Bertschi Antoinette, Geneva, Switzerland
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fasting Conditions.
- First Posted Date
- 2010-03-18
- Last Posted Date
- 2010-10-14
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Registration Number
- NCT01089192
- Locations
- 🇮🇳
Torrent Research Centre, Bhat, Gujarat, India
Bioequivalence Study of Metformin Hydrochloride Extended Release 750 mg Tablets Versus Glucophage XR® 750 mg Tablet in Healthy Volunteers Under Fed Conditions.
- First Posted Date
- 2010-03-18
- Last Posted Date
- 2010-07-29
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Registration Number
- NCT01089205
Bioequivalence Study of Metformin Hydrochloride Extended Release 500 mg Tablet Versus Glucophage XR® 500 mg Tablet in Healthy Volunteers Under Fed Conditions
- First Posted Date
- 2010-03-18
- Last Posted Date
- 2010-05-07
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Registration Number
- NCT01089179
- Locations
- 🇮🇳
Torrent Research Centre, Bhat, Gujarat, India
Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition
- First Posted Date
- 2010-03-18
- Last Posted Date
- 2010-06-22
- Lead Sponsor
- Torrent Pharmaceuticals Limited
- Registration Number
- NCT01089166
- Locations
- 🇮🇳
Torrent Research Centre, Bhat, Gujarat, India
Drug Development Updates
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