METFORMIN 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.
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NEWS HIGHLIGHTSMedia Articles Related to Metformin
Metformin Still Best as First Type 2 Diabetes Treatment Source: MedicineNet glipizide Specialty [2017.01.03] Title: Metformin Still Best as First Type 2 Diabetes Treatment Category: Health News Created: 1/3/2017 12:00:00 AM Last Editorial Review: 1/3/2017 12:00:00 AM
Pioglitazone, Sulfonylureas Safe and Effective in Type 2 Diabetes Source: Medscape Diabetes & Endocrinology Headlines [2017.09.29] They may not boast a cardiovascular benefit like other newer drugs, but these drugs can safely be added to metformin to manage type 2 diabetes. Medscape Diabetes & Endocrinology
Another SGLT2 Inhibitor, Ertugliflozin, Meets Goals in Two Trials Source: Medscape Diabetes & Endocrinology Headlines [2017.09.25] In two phase 3 trials, the SGLT2 inhibitor ertugliflozin for the treatment of type 2 diabetes that is uncontrolled with metformin alone or with sitagliptin demonstrated safety and efficacy at 52 weeks. Medscape Medical News
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
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.
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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 | | Rating |
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. |
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| Metformin review by 41 year old male patient | | Rating |
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.
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Side effects: | | none |
Comments: | | as prescribed |
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| Metformin review by 50 year old male patient | | Rating |
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. |
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Page last updated: 2017-09-29
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