Safety Efficacy of Four Anti-Diabetic treatment regimens in patients with Type 2 Diabetes during Ramadan Fasting: A comparative Study

Abstract

Objective: To compare the anti-hyperglycaemic effectiveness and safety of different anti-diabetic treatment regimens in fasting type 2 diabetic subjects during Ramadan.
Methods: This was a prospective four-week study of 161 subjects with type 2 diabetes (HbA1c 6.5-8.5%) during Ramadan, at the Department of Endocrinology & Metabolism, Services Hospital, Lahore, Pakistan. Study participants were randomized into four treatment groups: lifestyle modification only (group 1: lifestyle), metformin monotherapy (group 2: Metformin), metformin and sulfonylurea (group 3: Met/SU) and metformin and DPP4 inhibitor (group 4: Met/Sita). Anthropometric and biochemical evaluation were done one week before onset of Ramadan and in the last week of Ramadan. 134 patients completed the study protocol and repeated measures ANOVA was used to compare the groupsfor change inclinical and laboratory parameters from pre-Ramadan baseline.
Results: There was a significant decrease in mean blood glucose (mg/dL) and fructosamine(µmol/L)levels post-Ramadan in all treatment groups, with the greatest reduction seen in Met/Sita treatment group [(fructosamine -35.9, p <0.01), mean blood glucose (-23.6, p< 0.05)]. In the safety analysis, Met/Sita group also showed improvement in several metabolic parameters including lipid profile (cholesterol -12.4 mg/dL, p< 0.05; LDL -8.6mg/dL, p <0.05; triglycerides -41.9mg/dL, p <0.05) and transaminases. Only one patient among the study population reported a hypoglycaemic event (Met/SU group).
Conclusion: During Ramadan fasting, combination treatment with metformin-sitagliptinin type 2 diabetic subjects resulted in the greatest improvement in glycaemic control without causing hypoglycaemia, and was associated with improvement in lipid profile and hepatic transaminases.