ODP620 A Cross-over Trial Using Insulin Glargine And Neutral Protamine Hagedorn Insulin For The Poorly Controlled Patients With Type 2 Diabetes Who Refused Multiple Daily Insulin Injections

Abstract

Abstract A Cross-Over Trial Using Insulin Glargine and Neutral Protamine Hagedorn insulin for the Poorly Controlled Patients with Type 2 Diabetes Who Refused Multiple Daily Insulin Injections Background: Data in the literature describing the comparison between Neutral Protamine Insulin of Hagedorn (NPH) and glargine insulins are conflicting. While some studies revealed the superiority of Glargine, others had shown comparable results and even NPH superiority figures. We have many patients on NPH basal therapy in our clinical practice and another good number on Glargine. We did observe adverse effects in both groups, but local data and real numbers comparing both regimens are lacking. Objective To compare basal insulin regimen using NPH or Glargine in efficacy, hypoglycaemic events, and weight gain. Design and setting: A prospective interventional crossover study was conducted in Faiha Specialized Diabetes, Endocrine and Metabolism Center from 2018 through 2021, involving patients less than 65 years old with uncontrolled Type 2 Diabetes Mellitus whose HbA1c >10% on oral antidiabetic drugs (OAD); randomized into two groups (G1 & G2), 70 patients in each group had completed the study, one group received NPH and the other received Glargine in addition to their OAD for one year, then they were crossed over for another one year after a period of washout. Results The mean age was 48.9±5.5 and 45.9±4.1 years for G1 and G2, respectively. 36(51.4%) in G1 were women versus 27(38.6%) in G2. In the first phase of the study, HbA1c reduction was 5.5±1.1% for the NPH group and 5.3±1.1% for the Glargine group (p=0.418), there was 1.7±2.7 versus 1.1±2.9 Kg weight gain (p=0.209), 27(39.7%) hypoglycemic event versus 26(37.7%) (p=0.883) and 5 patients(7.4%) achieved HbA1c <7% versus 8(11.6%) (p=0.397) for the patients in NPH and Glargine groups respectively. While in the crossover phase, the data comparing Glargine and NPH groups are as following: 0.6±0.8 versus 0.5±0.9% reduction in HbA1c (p=0.413), 1.7±3.1 versus 0.6±2.2 Kg weight loss (p=0. 035) although the final weight was not much different 77.3±12. 0 versus 77.7±11.5 (p=0.841), 16(27.1%) versus 23(36.5%) hypoglycemic events (p=0.493) and 17(29.8%) versus 11(17.7%) achieved HbA1c<7% (p=0.121) respectively. Conclusion In our study, there was no significant difference in HbA1c reduction, Hypoglycemic events, and weight gain between patients using NPH or Glargine basal insulin regimen. Keywords: Diabetes; Glargine; NPH. Presentation: No date and time listed