Clinical Efficacy and Safety of Metformin in Prediabetics

Background: Prediabetes is defined as a state of abnormal glucose homeostasis, HbA1c 5.7% to 6.4% and fasting blood glucose 100 mg/dl to 125mg/dl. Mainstay of treatment in prediabetes is lifestyle changes. However if not controlled pharmacotherapy is added. Metformin HCL is a biguanide drug.Objectives: To evaluate clinical efficacy of metformin HCl with lifestyle modifications and to assess the adverse effects, safety profile and cost effectiveness of metformin in pre-diabetics. Materials and Methods: This randomized controlled clinical trial (RCT) was conducted at diabetic clinics of National Medical Centre and Bay View Hospital Karachi. Individual study duration was 3 months. This randomized controlled clinical trial (RCT) is registered at clinicaltrials.gov, bearing NCT number. Males and females, 17-40 years of age, were included. Metformin HCl was given 500 mg orally BD for 12 weeks alongwith lifestyle modification. Anthropometric parameters were evaluated at baseline week 6 and week 12. Metabolic parameters and safety profile parameters were evaluated at baseline and week 12. Adverse effects were assessed at 6 and week 12 whereas cost effectiveness at the end of study.Results: Majority of participants were in age group 32 to 40 years. Weight, HBA1c, FBS were highly significantly reduced, HDL was significantly increased. Metformin was found to be safe. No adverse effects were reported. Conclusion: Metformin is clinically effectively reduced weight, improved FBG and HbA1c in prediabetics. Metformin was safe for the dose and duration used and devoid of adverse effects in prediabetics. Metformin is very cost effective. Keywords: FBG, HbA1c, HCL, Lifestyle changes, Metformin HCL, Pre-diabetes, Weight.