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      A randomized multicentre trial of insulin glargine compared with NPH insulin in people with type 1 diabetes.

      Diabetes/Metabolism Research and Reviews
      Adolescent, Adult, Aged, Blood Glucose, metabolism, Diabetes Mellitus, Type 1, drug therapy, Drug Administration Schedule, Female, Hemoglobin A, Glycosylated, analysis, Humans, Hypoglycemia, etiology, Insulin, administration & dosage, adverse effects, analogs & derivatives, therapeutic use, Insulin Antibodies, Insulin, Isophane, Insulin, Long-Acting, Male, Middle Aged

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          Abstract

          To compare insulin glargine with NPH human insulin for basal insulin supply in adults with type 1 diabetes. People with type 1 diabetes (n = 585), aged 17-77 years, were randomized to insulin glargine once daily at bedtime or NPH insulin either once- (at bedtime) or twice-daily (in the morning and at bedtime) according to their prior treatment regimen and followed for 28 weeks in an open-label, multicentre study. Both groups continued with pre-meal unmodified human insulin. There was no significant difference between the two insulins in change in glycated haemoglobin from baseline to endpoint (insulin glargine 0.21 +/- 0.05% (mean +/- standard error), NPH insulin 0.10 +/- 0.05%). At endpoint, self-monitored fasting blood glucose (FBG) had decreased similarly in each group (insulin glargine -1.17 +/- 0.12 mmol/L, NPH insulin -0.89 +/- 0.12 mmol/L; p = 0.07). However, people on >1 basal insulin injection per day prior to the study had a clinically relevant decrease in FBG on insulin glargine versus NPH insulin (insulin glargine -1.38 +/- 0.15 mmol/L, NPH insulin -0.72 +/- 0.15 mmol/L; p < 0.01). No significant differences in the number of people reporting >or=1 hypoglycaemic episode were found between the two groups, including severe and nocturnal hypoglycaemia. Insulin glargine was well tolerated, with a similar rate of local injection and systemic adverse events versus NPH insulin. A single, bedtime, subcutaneous dose of insulin glargine provided a level of glycaemic control at least as effective as NPH insulin, without an increased risk of hypoglycaemia. Copyright (c) 2005 John Wiley & Sons, Ltd.

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