An Observation Study to Know the Importance of Voglibose in Prediabetes

This observation study was done in patients with prediabetes. Aim was to find out if early addition of OAD such as α-glucosidase inhibitor (voglibose), could prevent the development of type 2 diabetes in high-risk individuals or not.

Prediabetes is termed if patient has 1) Impaired Fasting Glucose (IFG) 2) Impaired Glucose tolerance (IGT). IFG is defined as when the Fasting blood glucose levels are between 100 to 125 mg/dL, and IGT is defined as when the two-hour glucose levels are between 140 to 199 mg/dL on the 75-g oral glucose tolerance test. A based on HbA1c also the prediabetes is considered when the levels are between 5.7 – 6.4%.

Methods:

Inclusion criteria:

• Men and women (19-67 years of age)
• HbA1c: 5.7-6.4%
• BMI between 20-29 kg/m2

• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus
• Pre-existing Cardiac Disease
• Pre-existing Renal Impairment (Serum Creatinine≥1.4 mg/dl for males or ≥1.2mg/dl in females)
• Elevated levels of Hepatic enzymes
• Creatine phosphokinase (greater than two times the upper limit of normal)
• Patients on pre-existing drug other OHA like Sulphonylurea, Insulin

40 patients were divided randomly into two groups comprising of 25 Patients each to group A (Study group) received voglibose 0.2mg twice a day, whereas in group B (placebo group) these 25 patient was advised only life style and diet modification only. The patients were followed up for a period of 6 months and efficacy of voglibose study group was compared to placebo group using SPSS statistical software and appropriate statistical tests.

In the present study group A and B patients FBS, PPBS HbA1C were compared and it was observed that there was no significant statistical significance observed between either groups during the pre-study. Post study after 6 months clearly shown beneficial results in terms of reduction of FBS, PLBS, and Hba1c.