Background:
Type 2 Diabetes is marked by varying degrees of insulin resistance and a progressive decline in the function of pancreatic β cells, this resulting in compromised insulin secretion leading to hyperglycemia and subsequent complications.
Aim:
This study aims to evaluate the efficacy and safety of Metformin Immediate Release (IR) versus Metformin Extended Release (ER) in patients with Type 2 Diabetes.
Methods:
In this parallel group, comparative, open label clinical study, patients (n = 70) were assigned to two groups: 35 patients were randomized to receive Metformin IR 500 mg tablet orally twice daily and the remaining 35 patients to receive Metformin ER 1000 mg tablet orally once daily for 12 weeks. Fasting Plasma Glucose (FPG), Postprandial Plasma Glucose (PPG) and Glycated Hemoglobin (HbA1c) were recorded at the start and end of study.
Results:
There was a significant decrease in FPG, PPG and HbA1c glycemic parameters from baseline to week 12 in both Metformin IR and Metformin ER groups but the difference was not statistically significant between the groups. Incidence of adverse effects were less reported with extended-release formulation. All patients tolerated both the formulations of metformin with good compliance.
Conclusion:
In this study both Metformin Immediate Release (IR) and Extended Release (ER) formulations demonstrated similar efficacy in improving glycemic control in drug naïve patients with type 2 diabetes. However, the ER formulation exhibited a superior safety profile, characterized by a reduced incidence of adverse effects, thereby could improve drug compliance.
Key words: Metformin extended release, Metformin immediate release, Glycemic efficacy, Tolerability, Type 2 diabetes
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