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Objective: Evaluation of the safety and efficacy of insulin detemir (IDet) in the observational and non-interventional PREDICTIVE study., Methods: A total of 2923 patients with type 1 or 2 diabetes on basal-bolus regimens were followed for 6 months: Group (1) NPH + human insulin (HI) bolus switching to IDet + analogue bolus (n = 349); Group (2) NPH + HI bolus switching to IDet + HI bolus (n = 500); Group (3) NPH + analogue bolus switching to IDet + analogue bolus (n = 1144); Group (4) Glargine + analogue bolus switching to IDet + analogue bolus (n = 704). Primary endpoint was major hypoglycaemia; change in HbA(1c), fasting plasma glucose, fasting plasma glucose variability and bodyweight were secondary endpoints., Results: These results need critical review due to the observational nature of the study (non-randomisation, no control group) as well as limitations of a possible study effect and the fact that some endpoints are based on patient recall, diaries or reports. Mean incidence of any hypoglycaemia was significantly reduced following the switch to insulin detemir therapy in all groups: the greatest reduction in total hypoglycaemia was in Group 1 from 42.38 to 20.28 episodes per patient-year (mean difference -22.10; p < 0.0001) and in nocturnal hypoglycaemia from 11.83 to 2.08 episodes/patient-year (mean difference -9.88; p < 0.0001). HbA(1c), FPG and FPG variability also improved significantly in all groups: the greatest reduction in HbA(1c) was in Group 1 from 8.13 to 7.42% (mean difference -0.71; p < 0.0001). Bodyweight was reduced in all groups., Conclusions: Whichever basal-bolus insulins were previously used, switching to insulin detemir as the basal insulin component resulted in significant lowering of hypoglycaemia, HbA(1c), FPG and bodyweight over a period of 6 months in patients with type 1 or 2 diabetes. Switching to an all-analogue regimen may be the most effective option when moving patients from human insulin-based basal-bolus regimens.

Background and Aims: Hepatic lipase (HL) catalyzes the hydrolysis of triglycerides and phospholipids from lipoproteins, and promotes the hepatic uptake of lipoproteins. A common G-250A polymorphism in the promoter of the hepatic lipase gene (LIPC) has been described. The aim was to study the effects of the G-250A polymorphism on HL activity, serum lipid profile and insulin sensitivity., Methods and Results: Altogether 151 healthy subjects (age 49+/-8 years, BMI 26.5+/-3.0kg/m(2)) were randomly assigned for 3 months to an isoenergetic diet containing either a high proportion of saturated fatty acids (SFA diet) or monounsaturated fatty acids (MUFA diet). Within groups there was a second random assignment to supplements with fish oil (3.6g n-3 FA/day) or placebo. At baseline, the A-250A genotype was associated with high serum LDL cholesterol concentration (P=0.030 among three genotypes). On the MUFA diet carriers of the A-250A genotype presented a greater decrease in LDL cholesterol concentration than subjects with other genotypes (P=0.007 among three genotypes). The rare -250A allele was related to low HL activity (P<0.001 among three genotypes). The diet did not affect the levels of HL activity among the genotypes., Conclusion: The A-250A genotype of the LIPC gene was associated with high LDL cholesterol concentration, but the MUFA-enriched diet reduced serum LDL cholesterol concentration especially in subjects with the A-250A genotype.