Glucophage dosage
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Glucophage Dosage: Insights from Recent Research
Bioequivalence of Glucophage Variants
Bioequivalence in Healthy Volunteers
Recent studies have focused on the bioequivalence of different formulations of metformin, including Glucophage® XR and its generic counterparts. A study conducted on healthy Chinese volunteers demonstrated that the generic metformin hydrochloride sustained-release (MH-SR) tablets (Boke®) are bioequivalent to the innovator product Glucophage®-XR (500 mg/tablet). The pharmacokinetic parameters such as the area under the curve (AUC) and maximum concentration (Cmax) were within the bioequivalence range of 80.00–125.00%1. Similarly, another study confirmed the bioequivalence of Glucophage tablets from Europe and the United States at both 500 mg and 1000 mg doses, ensuring that global clinical data can be used interchangeably2.
Extended-Release Formulations
The development of extended-release (XR) formulations of metformin, such as Glucophage® XR, has provided a once-daily dosing option, which is more convenient compared to the immediate-release (IR) formulations that require multiple doses per day. Studies have shown that the pharmacokinetic parameters of metformin XR are comparable to those of metformin IR, with no significant accumulation observed with multiple-dose administration3. This makes Glucophage® XR a viable option for patients seeking a simplified dosing regimen.
Efficacy and Safety of Glucophage XR
Dose-Response Relationship
The efficacy and safety of Glucophage® XR have been evaluated in patients with type 2 diabetes who had inadequate glycemic control despite diet and exercise. In two double-blind, placebo-controlled studies, different dosages of Glucophage® XR were assessed. The results indicated that Glucophage® XR is effective in improving glycemic control, with a clear dose-response relationship observed4.
Safety Profile
The safety profile of Glucophage® XR is consistent with that of the immediate-release formulation. Common adverse events include gastrointestinal issues, which are generally mild and transient. No severe adverse events were reported in the studies, making Glucophage® XR a safe option for long-term use1 3.
Comparative Studies with Other Formulations
Combination Therapies
In a study comparing the combination of glyburide/metformin (Glucovance™) with separate administration of glyburide and metformin, it was found that the combination tablet resulted in better postprandial glucose control. This suggests that fixed-dose combination tablets may offer superior glycemic control compared to separate administration of the individual components5.
Impact on Free Fatty Acids in PCOS
A study on women with polycystic ovary syndrome (PCOS) treated with Glucophage (500 mg twice daily) showed that while free fatty acid (FFA) levels remained unchanged, the treatment was effective in managing insulin resistance. This highlights the potential benefits of Glucophage in managing metabolic conditions beyond type 2 diabetes8.
Conclusion
The research indicates that Glucophage® and its extended-release formulations are effective and safe for managing type 2 diabetes. The bioequivalence of generic versions ensures that patients have access to cost-effective alternatives without compromising efficacy. Additionally, the extended-release formulations offer a convenient once-daily dosing option, improving patient adherence. Combination therapies and the impact on conditions like PCOS further expand the therapeutic potential of Glucophage.
Sources and full results
Most relevant research papers on this topic
Bioequivalence and safety evaluation of two preparations of metformin hydrochloride sustained-release tablets (Boke® and Glucophage®-XR) in healthy Chinese volunteers: a randomized phase I clinical trial
Both generic metformin hydrochloride sustained-release tablets (Boke®) and the innovator product (Glucophage®-XR) are bioequivalent and safe under fasting conditions in healthy Chinese participants.
RCTBioequivalence of Glucophage ® (Metformin) Tablets from Europe and the United States Tested in Healthy Volunteers
Glucophage tablets from Europe and the US are bioequivalent at doses of 1000 mg and 500 mg, and both markets are well-tolerated by healthy male and female subjects.
RCTSteady-State Pharmacokinetics of a Novel Extended-Release Metformin Formulation
The novel extended-release metformin XR tablet using GelShield Diffusion System technology has similar pharmacokinetic parameters and is well-tolerated at single doses up to 2000mg once daily for type 2 diabetes treatment.
Non-RCT
Highly CitedEfficacy, dose–response relationship and safety of once‐daily extended‐release metformin (Glucophage® XR) in type 2 diabetic patients with inadequate glycaemic control despite prior treatment with diet and exercise: results from two double‐blind, placebo‐controlled studies
Once-daily extended-release metformin (Glucophage® XR) effectively improves glycemic control in type 2 diabetic patients despite diet and exercise, with dose-dependent effects.
RCTHighly CitedPharmacokinetics and Pharmacodynamics of Glyburide/Metformin Tablets (Glucovance™) versus Equivalent Doses of Glyburide and Metformin in Patients with Type 2 Diabetes
Glybenclamide/metformin tablets (GlucovanceTM) result in lower postprandial glucose excursions in patients with type 2 diabetes, potentially contributing to better postprandial glycemic control than glibenclamide plus metformin separately.
RCTIBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study
IBI362 is a well-tolerated and effective treatment for overweight and obesity in Chinese adults, with mild adverse events and decreased appetite.
RCT
Rigorous JournalBioequivalence evaluation of two brands of metformin 500 mg tablets (Dialon® & Glucophage®) – in healthy human volunteers
Dialon® and Glucophage® are bioequivalent in terms of metformin 500 mg tablet bioavailability in healthy male volunteers.
RCTSerum free fatty acid levels in PCOS patients treated with glucophage, magnesium oxide and spironolactone
Spironolactone significantly decreases free fatty acid levels in PCOS patients, potentially lowering insulin resistance.
RCTBioavailability of metformin in tablet form using a new high pressure liquid chromatography assay method
Metformin is rapidly absorbed from this tablet formulation and rapidly eliminated, reaching equilibrium within 24 hours.
Non-RCT