Efficacy and safety of insulin glulisine in patients with type 1 diabetes.

Insulin glulisine (glulisine), a human insulin analogue with a rapid-acting time-action profile, has been developed to fulfil the mealtime (bolus) insulin requirement in patients with diabetes. The aim of this multinational, multi-centre, controlled, open-label, randomized, parallel-group study was to compare the efficacy and safety of insulin glulisine (glulisine) to that of insulin lispro (lispro) in adults diagnosed with Type 1 diabetes. Of the 683 patients randomized, 672 received treatment (339 patients received glulisine, 333 patients received lispro). Over the 26-week study, a similar reduction in mean HbA1c occurred in both groups (adjusted mean change from baseline -0.14% in both groups). The basal insulin dose was relatively unchanged from baseline in the glulisine group but increased in the lispro group (glulisine: 0.12 IU vs. lispro: 1.82 IU; p = 0.0001). As a consequence, total daily insulin dose decreased in the glulisine group but increased in the lispro group (glulisine: -0.86 IU vs. lispro: 1.01 IU; p = 0.0123). There was no relevant difference between the two groups in the reporting of symptomatic hypoglycaemia (overall, nocturnal and severe). This study demonstrates that glulisine provides equivalent glycaemic control to lispro. The clinical relevance of any difference in total daily insulin dose remains to be established.

Comparison of morphometric assessment of prevalent vertebral deformities in women using different reference data.

The semiquantitative assessment of vertebral deformities is based on visual evaluation. The quantitative approach is based on different morphometric criteria. This study is aimed at comparing the impact of different reference groups to define normal vertebral shape on the diagnosis of verterbral deformities. Reference normal values were obtained in three groups of women: French, mixed European, and Argentinian. All these women had normal lumbar spine bone mineral density and no vertebral deformities according to the semiquantitative assessment. In a group of 135 women having vertebral deformities according to Genant's semiquantitative assessment, three different morphometric criteria were applied. Morphometric diagnosis disclosed a good agreement with semiquantitative assessment. Agreement of diagnosis was higher for a given cutoff using thresholds obtained in different reference groups (kappa = 0.84-0.96) and lower when different criteria were compared using thresholds obtained in the same reference group (kappa = 0. 75-0.85). When fracture thresholds obtained in three different cohorts were compared separately for the three morphometric criteria, agreement was the highest when the cutoff was based only on the arithmetical mean of vertebral heights and was independent of its standard deviation (SD). Average vertebral height ratios did not differ between the three reference cohorts, whereas SDs of vertebral height ratios were the highest in the mixed European cohort and the lowest in the French cohort (F = 7.41, p < 0.001). In the three groups of women of different nationality, SDs of vertebral height ratios, but not the arithmetical means, were significantly higher in the radiographs of poor quality compared with those of good quality. Thus, the main source of difference of diagnosis was related to different SDs whereas average height ratios were not different. Differences in SDs between the three groups were found to be related, at least partly, to poor quality of radiographs. The impact of the differences between populations seems less important, however, only three countries were compared. These findings suggest that those techniques that take into account the SD of vertebral height ratios will provide different reference values for vertebral morphometry. Because differences in SDs depend mainly on the quality of radiographs, they can be reduced by improving the X-ray technique and by the use of standardized protocols. This variability will result in the identification of a variable number of vertebral deformities in osteoporotic women. These results may be of importance especially for multicentric studies.