Insulin lispro improves postprandial glucose control in patients with diabetes mellitus.
ABSTRACT Insulin lispro was compared with regular human insulin with respect to glycaemic control in patients with diabetes mellitus on intensive insulin treatment. Sixty-two patients (55 type 1; 7 type 2) from eight study centres in the Czech Republic, Slovenia and the Slovak Republic participated in a 4-month, open-label, randomized, crossover study. Patients administered insulin lispro immediately before meals or regular human insulin 30 min before meals. A test meal (220-400 kcal), based on local and individual dietary habits and consistent for each patient throughout the study was given at baseline and at the end of each treatment. At each test meal visit HbA1c, fasting blood glucose, 1-hour and 2-hour postprandial blood glucose levels were measured. The level of HbA1c (7.6% +/- 1.5% versus 7.4% +/- 1.5%), incidence of hypoglycaemia (41-66% of patients--versus 39-63%) and daily insulin dose (0.67 +/- 0.11 U/kg versus 0.65 +/- 0.11 U/kg) did not differ between treatment groups at endpoint (insulin lispro versus regular human insulin, respectively). Mean 2-hour postprandial blood glucose excursion for the insulin lispro group (0.0 +/- 3.7 mmol/L) was significantly lower (p = 0.035) when compared with the regular human insulin group (1.3 +/- 3.7 mmol/L) at endpoint. Therapy with insulin lispro was therefore associated with a significant improvement in postprandial blood glucose excursion control when compared with regular human insulin, without an increase in rate of hypoglycaemia.
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ABSTRACT: To determine the long-term health economic benefits associated with lispro vs. regular human insulin (RHI) in UK Type 1 diabetic (T1DM) patients using the previously published and validated CORE Diabetes Model. A literature review designed to capture clinical benefits associated with lispro and T1DM cohort characteristics specific to UK was undertaken. Clinical benefits were derived from a Cochrane meta-analysis. The estimated difference (weighted mean) in glycated haemoglobin (HbA(1c)) was -0.1% (95% confidence interval -0.2 to 0.0%) for lispro vs. RHI. Severe hypoglycaemia rates for lispro and RHI were 21.8 and 46.1 events per 100 patient years, respectively. Costs and disutilities were accounted for severe hypoglycaemia rates. All costs were accounted in 2007 poundUK from a National Health Service (NHS) perspective. Future costs and clinical benefits were discounted at 3.5% annually. In the base-case analysis, lispro was projected to be dominant compared with RHI. Lispro was associated with improvements in quality-adjusted life expectancy (QALE) of approximately 0.10 quality-adjusted life years (QALYs) vs. RHI (7.60 vs. 7.50 QALYs). Lifetime direct medical costs per patient were lower with lispro treatment, pound70 576 vs. pound72 529. Severe hypoglycaemia rates were the key driver in terms of differences in QALE and lifetime costs. Sensitivity analyses with assumptions around time horizon, discounting rates and benefits in terms of glycaemic control or hypoglycaemic event rates revealed that lispro remained dominant. Our findings suggest that lispro is likely to improve QALE, reduce frequency of diabetes-related complications and lifetime medical costs compared with RHI.Diabetic Medicine 09/2009; 26(8):803-14. · 3.24 Impact Factor
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ABSTRACT: This study aimed to compare the effect of treatment with short-acting insulin (SAI) analogues versus structurally unchanged short-acting insulin (regular insulin) on glycaemic control and on the risk of hypoglycaemic episodes in type 1 diabetic patients using different insulin treatment strategies. We performed a meta-analysis of 27 randomised controlled trials that compared the effect of SAI analogues with regular insulin in patients with type 1 diabetes mellitus. The treatments were administered either via continuous subcutaneous insulin infusion (CSII) or by conventional intensified insulin therapy (IIT) with short-acting insulin injections before meals and basal insulin administered once or twice daily in most cases. HbA(1)c levels were reported for 20 studies. For studies using CSII, the weighted mean difference between values obtained using SAI analogues and regular insulin was -0.19% (95% CI: -0.27 to -0.12), whereas the corresponding value for injection studies was -0.08% (95% CI: -0.15 to -0.02). For the analysis of overall hypoglycaemia, we used the results from nine studies that reported the mean frequency of hypoglycaemic episodes per patient per month. For studies using CSII, the standardised mean difference between SAI analogues and regular insulin was -0.07 (95% CI: -0.43 to 0.28), whereas for IIT studies the corresponding value was -0.04 (95% CI: -0.24 to 0.16). Taking into consideration the low quality of the trials included, we can conclude that use of a short-acting insulin analogue in CSII therapy provides a small, but statistically significant improvement in glycaemic control compared with regular insulin. An even smaller effect was obtained with the use of ITT. The rate of overall hypoglycaemic episodes was not significantly reduced with short-acting insulin analogues in either injection regimen.Diabetologia 12/2004; 47(11):1895-905. · 6.49 Impact Factor