Safety and efficacy of different basal insulin in type 2 diabetes mellitus with chronic kidney disease in Ramadan: prospective observational study

BACKGROUND: Diabetic kidney disease populations are categorized as high risk for fasting in Ramadan due to various potential fasting-related complications. Insulin analogues are recommended to be used in place of human insulin during fasting, as they carry a lower risk of hypoglycaemia and stable glycaemic variability. A paucity of data exits on the safety and efficacy of different basal insulin types during fasting for this population. This study aims to evaluate the safety and efficacy of three basal insulin among patients with Type 2 Diabetes Mellitus and concomitant mild to moderate chronic kidney disease who are keen to fast during Ramadan.

MATERIALS AND METHODS: A single-centered, prospective observational study was conducted among 46 patients with type 2 diabetes mellitus and concomitant chronic kidney disease stage 2 and 3 who were on three different types of basal insulin (Glargine U-100, Levemir, and Insulatard), fasted in Ramadan 2022. All variables were listed as median (IQR). Hypoglycaemia events and glycemic variability obtained from Freestyle Libre continuous glucose monitoring were compared between insulin groups. Changes in glycated haemoglobin, fasting plasma glucose, renal profile, body weight, body mass index, and waist circumference pre and post-Ramadan were evaluated.

RESULTS: The glycaemic variability was found highest in Insulatard with a median (IQR) of 37.2(33)% versus Levemir 34.4(32.4)% versus Glargine U-100 36.8(30.6)%, p = NS. Levemir had reported the lowest median time of below range of 2.5(13)% followed by Glargine 4(25)% and Insulatard 5(8)%; p = NS. The findings of this study indicated that glycated haemoglobin, fasting plasma glucose, renal profile, body weight, body mass index, and waist circumference did not alter statistically between the three groups post-Ramadan. Individually, Insulatard showed a significant reduction in weight and waist circumference (0.9kg, p = 0.026; 0.44 cm, p = 0.008) while Levemir showed a reduction in waist circumference (0.75cm, p = 0.019).

CONCLUSION: This study revealed that Insulatard, Levemir, and Glargine demonstrated similar levels of safety and efficacy among those with diabetic kidney disease who observed fasting during Ramadan.