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Metformin (Metformin Hydrochloride) - Summary



Metformin Hydrochloride (HCl) Tablets, USP is an oral antihyperglycemic drug used in the management of type 2 diabetes.

Metformin HCl Tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus.

See all Metformin indications & dosage >>


Published Studies Related to Metformin

Anagliptin and sitagliptin as add-ons to metformin for patients with type 2 diabetes: a 24-week, multicentre, randomized, double-blind, active-controlled, phase III clinical trial with a 28-week extension. [2015]
We conducted a 24-week, multicentre, double-blind, randomized study with a 28-week extension to compare the efficacy and safety of anagliptin and sitagliptin as an add-on to metformin in patients with type 2 diabetes. Patients inadequately controlled on metformin were randomized to either anagliptin (100 mg twice daily, n = 92) or sitagliptin (100 mg once daily, n = 88)...

Effect of combination therapy with repaglinide and metformin hydrochloride on glycemic control in Japanese patients with type 2 diabetes mellitus. [2014]
exercise... CONCLUSIONS: Combination therapy with repaglinide and metformin resulted in an

Lipid profiling reveals different therapeutic effects of metformin and glipizide in patients with type 2 diabetes and coronary artery disease. [2014]
CONCLUSIONS: Our findings revealed the differential therapeutic effects of

Metformin for non-diabetic patients with coronary heart disease (the CAMERA study): a randomised controlled trial. [2014]
diabetes... INTERPRETATION: Metformin had no effect on cIMT and little or no effect on

The effect of metformin on apoptosis in a breast cancer presurgical trial. [2013]
presurgical trial... CONCLUSION: Overall, we found no significant modulation of apoptosis by

more studies >>

Clinical Trials Related to Metformin

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin [Completed]
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of metformin. Safety and tolerability of isavuconazole will be assessed alone and in combination with metformin.

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers [Terminated]
This is a an open-label, randomized, single dose, four-way crossover, multi-stage study enrolling 20 healthy adult male and female subjects per part. This study consists of two separate parts (Part A and B) with each part comprising four treatment periods. Each subject will participate in all four treatment periods per part; Subjects may not enrol in both Parts A and B. This study is being conducted to compare the pharmacokinetics (PK) of two extended release fixed dose combinations (FDC) oral formulations of metformin and glimepiride at two doses, 500mg/1mg and 1000mg/2mg, with each FDC formulation to be administered orally as a single dose and compared with the commercially available formulations of metformin extended release (XR) (GLUCOPHAGE ™ Sustained Release [SR]) and glimepiride immediate release (IR) (AMARYL ™). Part A of study will evaluate the bioavailability of a formulation comprising a film coated tablet containing release controlling polymers; and Part B will evaluate the bioavailability of a formulation comprising a tablet coated with release controlling polymers. In each part there will be 4 treatment periods. During each period, subjects will be randomized sequentially to receive a single dose of a reference treatment of 500 mg metformin XR / 1 mg glimepiride IR; and a reference treatment of 1000 mg metformin XR / 2 mg glimepiride IR; and an FDC tablet containing 500 mg metformin XR and 1 mg glimepiride XR; and an FDC tablet containing 1000 mg metformin XR and 2 mg glimepiride XR. Serial PK sampling for up to 36 hours and safety assessments will be performed. Each period will be separated by a washout period of at least 5 days and a follow-up visit will occur 14 days after the last dose of study drug.

A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets [Completed]

An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients [Active, not recruiting]
Study NS-0100-01E is an extension of Study NS-01-0100 designed to assess safety and longer term effect (i. e., additional 8 weeks) of various fixed-dose leucine and metformin combinations (NS-0100) versus standard metformin monotherapy on glycemic control in subjects with type 2 diabetes using HbA1c as the primary endpoint.

Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers [Completed]
Metformin Glycinate is a novel biguanide compound developed as a potential candidate for the treatment of type 2 diabetes. Metformin Glycinate was found to improve metabolic control in naive patients with type 2 diabetes. The objective of this study is to evaluate the safety, tolerability and pK profile of Metformin Glycinate 620 mg QD, 1240 mg QD, 2480 mg QD, after administration of one single dose, in step A. In step A will be included 25 volunteers. In step B the objective is to evaluate Safety, tolerability and pK profile of Metformin Glycinate 620 mg BID, after administration of multiple dose during 8 days. In step B will be included 24 volunteers.

more trials >>

Reports of Suspected Metformin Side Effects

Renal Failure Acute (5)Hypotension (4)Lactic Acidosis (3)Suicide Attempt (3)Intentional Overdose (2)Hypoglycaemia (2)Completed Suicide (2)Blood Creatinine Increased (2)Dyspnoea (2)Diarrhoea (2)more >>


Based on a total of 20 ratings/reviews, Metformin has an overall score of 8.05. The effectiveness score is 8.20 and the side effect score is 8.20. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Metformin review by 30 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Severe Side Effects
Treatment Info
Condition / reason:   pcos
Dosage & duration:   2000mg/day taken twice a day for the period of 4 months
Other conditions:   none
Other drugs taken:   none
Reported Results
Benefits:   As for Polycystic Ovary Syndrome patient, the main goal of the treatment was to regulate ovulation, and to regulate menstrual period. After 4 months of treatment (only 2 months therapeutic dose), I become pregnant and now have a beautiful son.
Side effects:   Persistant nausea, diarrhea after every single dose.
Comments:   Treatment started as a very low dose at 500mg/day at the evening meal. Dose was increased by 500mg on the second week and stayed the same for 3 weeks. On week 5 dose was increased by 500mg for another 2 weeks. Another 500mg increase up to 2000mg/day until beginning of the pregnancy.


Metformin review by 41 year old male patient

Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   none
Dosage & duration:   2 g a day (dosage frequency: twice) for the period of 1 year
Other conditions:   none
Other drugs taken:   alpha-lipoic acid
Reported Results
Benefits:   Well... what can I say? During the treatment I mentioned a considerable pressure decrease, and for sure it was a notable blood sugar decrease. I would recommend this drug to evedybody with sugar diabetes type II. Adherence to a diabetic diet is an important aspect of controlling elevated blood sugar in patients with diabetes. The American Diabetes Association (ADA) has provided guidelines for a diabetic diet. The ADA diet is a balanced, nutritious diet that is low in fat, cholesterol, and simple sugars. The total daily calories are evenly divided into three meals. In the past two years, the ADA has lifted the absolute ban on simple sugars. Small amounts of simple sugars are allowed when consumed with a complex meal. For more, please read the Diabetic Diet article.
Side effects:   none
Comments:   as prescribed


Metformin review by 50 year old male patient

Overall rating:  
Effectiveness:   Marginally Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   diabetes
Dosage & duration:   max allowed (dosage frequency: daily) for the period of 120 days
Other conditions:   high blood pressure; depression; sleep apnea
Other drugs taken:   aspirin, Lasix
Reported Results
Benefits:   There was no perceptible benefit to the patient from his point of view; there was an apparent improvement as measured by the doctor. The doctor advised continuation of the treatment.
Side effects:   There was no perceptible side effect experienced by the patient; this is possibly possibly due to the inattentive nature of the patients deep depression. The patient also had extreme sleep apnea.
Comments:   Started the treatment for 60 days at maximum recommended rate; the patient found no perceptible improvement he then trailed off to stop treatment over the following 60 days.

See all Metformin reviews / ratings >>

Page last updated: 2015-08-10

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