# Safety and Effectiveness of Insulin Degludec in Patients With Type 2 Diabetes Mellitus With Chronic Liver Disease

## TL;DR

This study shows that insulin degludec is effective and safe for managing diabetes in patients with chronic liver disease, with minimal severe hypoglycemia.

## Contribution

The study provides evidence for the safety and effectiveness of insulin degludec in patients with type 2 diabetes and chronic liver disease.

## Key findings

- Insulin degludec significantly reduced glycemic parameters like HbA1c, fasting, and postprandial glucose.
- Only 14.3% of patients experienced mild or nocturnal hypoglycemia, with no severe cases reported.
- Most patients had mild-to-moderate liver impairment and showed improvement after treatment.

## Abstract

Background

Managing patients with type 2 diabetes mellitus (T2DM) with chronic liver disease (CLD) is challenging due to an increased risk of hypoglycemia. Among other long-acting basal insulin analogs, insulin degludec has been shown to have a low risk of hypoglycemic events in patients with T2DM.

Aim

To evaluate the effectiveness of insulin degludec in managing T2DM in patients with CLD based on changes in glycated hemoglobin (HbA1c), fasting plasma glucose, and postprandial glucose (PPG) levels, and to evaluate its safety, based on the incidence of hypoglycemic events.

Methods

This single-center, observational, retrospective study was conducted using data from 35 patients, aged between 18 and 75 years, with T2DM, a body mass index (BMI) of <40 kg/m2,and stable hepatic impairment based on the Child-Pugh classification. Data, including demographics, laboratory results, and medical history, were collected from electronic medical records at baseline and three months after treatment with insulin degludec. The primary endpoints were the number and severity of hypoglycemic events, as well as changes in glycated hemoglobin (HbA1c.), fasting plasma glucose (FPG), and postprandial glucose (PPG) levels. A p-value of <0.05 was considered statistically significant.

Results

Among the 35 patients enrolled in the study, the majority (n=25) were males. Most of the patients had been living with T2DM for a mean duration of 10.79±5.63 years and had mild-to-moderate hepatic impairment based on Child-Pugh scores. Most of the patients (15, 42.9%) were on a combination of sulfonylurea and insulin at baseline. Significant reductions in glycemic parameters were observed from baseline to three months after treatment (p<0.001). About 14.3% of patients developed level 1 hypoglycemia, another 14.3% developed nocturnal hypoglycemia, and none reported level 2 or 3 hypoglycemia.

Conclusion

Insulin degludec improved glycemic parameters while reducing the risk of severe hypoglycemic events. The study findings suggest that insulin degludec can be considered a safe option for patients with T2DM with CLD. However, prospective studies with larger sample sizes and a comparator arm are warranted to highlight insulin degludec’s potential in this patient population.