Comparison of insulin detemir and insulin glargine in subjects with type 1 diabetes using intensive insulin therapy

WSTĘP. Celem niniejszej pracy było porównanie kontroli glikemii oraz ryzyka hipoglikemii podczas stosowania insuliny detemir 2 × dziennie lub glarginy raz dziennie u chorych na cukrzycę typu 1. MATERIAŁ I METODY. Podczas trwającego 26 tygodni wieloośrodkowego, otwartego badania z grupami równoległymi 320 chorym na cukrzycę typu 1 podawano albo insulinę detemir 2 × dziennie albo glarginę raz dziennie, każdorazowo w połączeniu z przedposiłkowymi iniekcjami insuliny aspart. WYNIKI. Po 26 tygodniach wartość HbA1c zmniejszyła się z 8,8% do 8,2% w grupie przyjmującej insulinę detemir i z 8,7% do 8,2% w grupie leczonej glarginą. Wartość stężenia glukozy w osoczu (PG) mierzonego na czczo w domu była niższa podczas stosowania glarginy niż w czasie podawania insuliny detemir (7,0 mmol/l vs. 7,7 mmol/l; p < 0,001). Ogólny 9-punktowy profil mierzonych w domu wartości glikemii był porównywalny między grupami (p = 0,125). Nie stwierdzono istotnej różnicy w zmienności pomiarów PG u 1 pacjenta (p = 0,437). Zróżnicowanie pomiarów przedposiłkowego stężenia PG u 1 badanego było niższe podczas stosowania insuliny detemir niż glarginy (p < 0,05). Ogólne ryzyko hipoglikemii było podobne, nie stwierdzono różnic w występowaniu potwierdzonych epizodów hipoglikemii. Ryzyko silnej, nocnej hipoglikemii wynosiło odpowiednio: 72% i 32% i było niższe w grupie stosującej insulinę detemir (p < 0,05). Zwiększenie masy ciała nie różniło się znacząco między grupami przyjmującymi insulinę detemir i glarginę (0,52 kg vs. 0,96 kg; p = 0,193). WNIOSKI. Leczenie insuliną detemir podawaną 2 × dziennie lub glarginą podawaną raz dziennie, każdorazowo w połączeniu z insuliną aspart, powodowało podobną kontrolę glikemii. Ogólne zagrożenie hipoglikemią było porównywalne, natomiast ryzyko nasilonej i nocnej hipoglikemii było istotnie niższe podczas stosowania insuliny detemir.BACKGROUND. To compare glycaemic control and risk of hypoglycaemia of twice-daily insulin detemir with once-daily insulin glargine in subjects with type 1 diabetes. MATERIAL AND METHODS. In this 26-week, multicentre, open-label, parallel-group trial, 320 subjects with type 1 diabetes received either insulin detemir twice daily or insulin glargine once daily, each in combination with premeal insulin aspart. RESULTS. After 26 weeks, HbA1c had decreased from 8.8 to 8.2% in the insulin detemir group and from 8.7% to 8.2% in the insulin glargine group. Homemeasured fasting plasma glucose (PG) was lower with insulin glargine than with insulin detemir (7.0 mmol/l vs. 7.7 mmol/l; p < 0.001). The overall shape of the home-measured nine-point PG profiles was comparable between treatments (p = 0.125). Overall, there was no significant difference in within-subject variation in PG (p = 0.437). Withinsubject variation in predinner PG was lower with insulin detemir than with insulin glargine (p < 0.05). The overall risk of hypoglycaemia was similar with no differences in confirmed hypoglycaemia. However, the risk of severe and nocturnal hypoglycaemia was 72% and 32%, respectively, lower with insulin detemir than with insulin glargine (p < 0.05). Body weight gain was not significantly different comparing insulin detemir and insulin glargine (0.52 kg vs. 0.96 kg, p = 0.193). CONCLUSIONS. Treatment with twice-daily insulin detemir or once-daily insulin glargine, each in combination with insulin aspart, resulted in similar glycaemic control. The overall risk of hypoglycaemia was comparable, whereas the risks of both severe and nocturnal hypoglycaemia were significantly lower with insulin detemir

Trace elements and essential oil composition in chemotypes of the aromatic plant Origanum vulgare

Trace elements, essential oil yield and its percentage composition were determined by neutron activation analysis, hydrodistillation and gas chromatography in two chemotypes of Origanum vulgare L. cultivated in the same field. Statistical tests such as analysis of variance, correlation coefficient, t-test, and multiple correlation were applied. The results showed that the samples contain the highest recorded oil yield for aromatic plants. Also, there is a statistically significant difference between the chemotypes of the plant not only in the predominant compound but in a number of other components. Iron, chromium and scandium showed a negative significant correlation with carvacrol and a positive one with thymol. Europium shows characteristic correlations with chromium, cobalt, iron and scandium within each chemotype of the plant. These correlations could make probable a role of this element in the biosynthesis of the predominant compounds

Statistical study of essential oil composition in three cultivated sage species

The essential oil yield and composition of Salvia officinalis L., S. pomifera L. and two leaf variations of S. fruticosa Mill, cultivated in the same field, were determined by hydrodistillation and gas chromatography. In the analytical data statistical tests such as analysis of variance, correlation coefficient, chi-square test, t-test, and multiple correlation were applied. The results showed that there is a statistically significant difference between the species/variations for all the studied oil constituents. Also the difference is significant for some constituents between the two leaf variations of S. fruticosa. Many significant correlation coefficients and multiple correlation coefficients between the different constituents within each Salvia species were found. Some other correlations are found significant within S. pomifera only. The last ones could characterize the chemotype of this species probably. © 1998, Taylor &amp; Francis Group, LLC. All rights reserved

Long-term efficacy and safety of insulin detemir compared to Neutral Protamine Hagedorn insulin in patients with Type 1 diabetes using a treat-to-target basal-bolus regimen with insulin aspart at meals: A 2-year, randomized, controlled trial

Aims: This 24-month, multi-national, open-label, parallel group trial investigated the long-term efficacy and safety of insulin detemir and Neutral Protamine Hagedorn insulin in combination with mealtime insulin aspart in patients with Type 1 diabetes using a treat-to-target concept. Methods: Patients were randomized 2 : 1 to detemir (n = 331) or NPH (n = 166) groups. Basal insulin was initiated once daily (evening) and titrated individually based on self-measured plasma glucose (PG) levels, aiming for pre-breakfast and pre-dinner targets ≤ 6.0 mmol/l. A second basal morning dose could be added according to pre-defined criteria. Results: After 24 months, superiority of glycated haemoglobin (HbA) was achieved with detemir compared to NPH (detemir 7.36%, NPH 7.58%, mean difference -0.22% points) [95% confidence interval (CI) -0.41 to -0.03%], with reductions of 0.94% and 0.72% points, respectively. Fasting PG (FPG) was also lower with detemir (detemir 8.35 mmol/l, NPH 9.43 mmol/l; P = 0.019). Twenty-two per cent of patients treated with detemir reached an HbA ≤ 7.0% in the absence of confirmed hypoglycaemia during the last month of treatment vs. 13% on NPH (P = 0.019). Risk of major and nocturnal hypoglycaemia was 69% and 46% lower with detemir than with NPH (P < 0.001), respectively; patients treated with detemir gained less weight (detemir 1.7 kg, NPH 2.7 kg; P = 0.024). The overall safety profile was similar in the two groups and treatment with detemir did not result in any unexpected findings. Conclusions: Long-term treatment with the insulin analogues detemir + aspart was superior to NPH + aspart in reducing HbA, with added benefits of less major and nocturnal hypoglycaemia and less weight gain

Analisi di impatto sul budget di differenti analoghi ad azione rapida dell’insulina in Italia

Introduction: Rapid-acting insulins are the current standard of care in diabetes management. Insulin aspart (IA), lispro (IL) and glulisine (IG) demonstrated similar efficacy and safety. However, their impact on the National Health Service (NHS) expenditure could be a relevant differentiating factor. Objective: The study aims to assess the budget impact of IG increased market share in a new scenario vs. current case. Method: A budget impact model built in MS Excel (2010) estimated the impact of IG on the Italian NHS expenditure. Input data were derived from published sources. Pharmaceutical expenditure for considered treatments was estimated on retail or hospital prices and no price modifications were assumed. A scenario analysis was conducted by varying the IG market shares. Results: In the current scenario, IG market share 17.2%, the NHS expenditure is respectively €245-250 million at first and third year. Increasing the IG market share of 35% more of the current scenario, at first year and more of 50% at the following two years , the NHS expenditure reduces to €244.3, €245.0 and €244.8 million in the three years with cumulative, savings around € 8.8 million at third year. The scenario analysis shows that, increasing the IG market shares from 17.2% to 26% at first year, it is possible to achieve savings for almost 10.7 million at third year. Conclusions: IG, besides being as effective and safe as IL and IA, is less expensive and can reduce the financial burden to the Italian NHS up to €8.8 million at third year

Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 1 diabetes (BEGIN Basal-Bolus Type 1): a phase 3, randomised, open-label, treat-to-target non-inferiority trial.

Intensive basal-bolus insulin therapy has been shown to improve glycaemic control and reduce the risk of long-term complications that are associated with type 1 diabetes mellitus. Insulin degludec is a new, ultra-longacting basal insulin. We therefore compared the efficacy and safety of insulin degludec and insulin glargine, both administered once daily with mealtime insulin aspart, in basal-bolus therapy for type 1 diabetes