A Randomized, Open-label, Parallel-group Study to Compare the Efficacy and Safety of Volv(superscript ®) (Metformin IR) versus Glucophage(superscript ®) (Metformin IR) for the Treatment of Type 2 Diab

Abstract

Metformin, a biguanide derivative, has been used as an antihyperglycemic agent. The first product of metformin, Glucophage(superscript ®) (Metformin Immediate Release, IR), was introduced into the market by Bristol-Myers Squibb. In Taiwan, Y.S.P. Ind. Co., LTD. has also developed Volv(superscript ®) (Metformin IR). The purpose of this randomized, open-label, parallel-group study is to compare the efficacy and safety of Volv(superscript ®) versus Glucophage(superscript ®) for the treatment of type 2 diabetes mellitus. Based on the blocked random number generation program, the treatment (Volv(superscript ®)) and control (Glucophage(superscript ®)) groups included 28 and 30 subjects. In both treatment and control groups, 24 and 22 subjects completed the study, 2 and 3 subjects failed to complete the study due to adverse reactions, and 2 and 5 subjects were not compliant. The treatment regimen, including metformin alone or in combination with sulfonylurea/meglitinide, and final dosage of metformin were not different between treatment and control groups. Intention-to-treat analysis showed there were a significant decrease in HbA1c and fasting plasma glucose (FPG) during 5-month treatment within both treatment and control groups. The final HbA1c and FPG levels were not significantly different between treatment and control groups after adjustment for the initial levels (HbA1c, p=0.341; FPG, p=0.555). The rates of achieving the therapeutic goal with HbA1c ＜7% were also not different between treatment (35.7%) and control (36.7%) groups. The lipid profile, body weight, blood pressure, hepatic and renal function, electrolyte, and hematology data were not significantly different between and within the treatment and control groups, except the plasma sodium level within the control group and the total cholesterol between the treatment and control groups. The rates of adverse events were also not significantly different between these two groups. The most common adverse event was diarrhea that appeared in 17.9 and 26.7% of the treatment and control groups. Except severe diarrhea in 2 subjects of control group, all the adverse reactions were not severe and the events improved or completely subsided as treatment was continued. In conclusion, Volv(superscript ®) therapy at a dose of 500-2000 mg daily is as effective and tolerated as Glucophage(superscript ®) therapy in the aspect of reducing blood glucose level for the treatment of type 2 diabetes mellitus.