Glargine versus NPH insulin: Efficacy in comparison with insulin aspart in a basal bolus regimen in type 1 diabetes - The glargine and aspart study (GLASS) - A randomised cross-over study

The aim of the study was to compare the efficacy of insulin glargine and aspart with NPH insulin and aspart in a basal bolus regimen in type I diabetes. In this 36-week randomised open-label two-period cross-over trial, subjects received 16 weeks' treatment with either once-daily insulin glargine or twice-daily NPH insulin after 4-week run-in. Primary outcome was HbAlc and secondary outcomes were fasting plasma glucose (FPG), weight change, incidence of hypoglycaemia, effect on lipid profile and patient satisfaction. Sixty patients with type I diabetes were recruited (33 male, mean age 42.7 years, mean HbAlc 8.53%) with 53 completing the study. At completion, HbAlc was lower with glargine and aspart than with NPH and aspart (8.07% versus 8.26%, difference -0.19 [95% CI 0.37-0.0 1]%, p = 0.04). FPG was significantly different between glargine and NPH (p = 0.002), with mean FPG on glargine 3 mmol/L lower than on NPH at the end of the study. There were no differences in hypoglycaemia rate (p = 0.63), weight (p = 0.45) or lipid profile (p = 0.18), Patient satisfaction was greater with glargine (DTSQ, p = 0.001). Three patients discontinued as they wished to remain on glargine. We suggest that glargine combined with aspart is an effective basal bolus regimen in type I diabetes. (C) 2006 Elsevier Ireland Ltd. All rights reserved.