IRWIS (IDegLira Real world Indian Study): A Real-World Observational Study For Use of IDegLira In Indian Patients

Abstract

IntroductionNovel therapies, like the fixed dose coformulation of insulin degludec (100 U/ml) and liraglutide (3.6 mg/ml) (IDegLira), are key to achieving glycemic targets in some patients with difficult to control diabetes. Our objective was to evaluate the efficacy and safety of IDegLira in Indian patients with type 2 diabetes mellitus that was inadequately controlled on multiple oral anti-diabetic agents with or without insulin therapy. MethodsThis was a multicenter, retrospective, real-world observational study. Clinical case records were analyzed for 61 patients with poorly controlled type 2 diabetes mellitus (HbA1c >8.5%) who were treated with IDegLira over a 26-week period. ResultsThere were significant reductions in mean fasting (112.51± 24.80 vs. 188.48 ± 52.19 mg/dl; P <0.001) and postprandial plasma glucose levels (166.21 ± 29.12 vs. 289.19 ± 98.75 mg/dl; P <0.001) and HbA1c (7.61 ± 0.92 vs. 9.81 ± 1.78%; P <0.001) after 26 weeks of treatment with IDegLira. There were significant changes in mean weight (79.82 ± 10.75 vs. 86.58 ± 10.79 kg) and BMI (30.92 ± 3.86 vs. 33.17 ± 4.01kg/m2). While there was no significant decrease in diastolic blood pressure, there was a drop of around 4 mm in systolic blood pressure. Eleven episodes of hypoglycaemia were reported in 6 patients. No patients reported any episodes of serious adverse events. ConclusionsIDegLira had significant beneficial effects on glycaemic control and body weight over a 6-month period in Indian patients with type 2 diabetes that was poorly controlled on multiple oral anti-diabetic agents with or without insulin therapy. IDegLira was also found to be safe in this patient population.