Naslov
Efficacy and safety of insulin detemir compared with NPH insulin for women with type-1 diabetes mellitus

Autori
Ivanišević, Marina ; Đelmiš, Josip

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, stručni

Izvornik
41st Annual meeting of DPSG / DPSG - Frascati : DPSG, 2009, 35-35

Skup
41st Annual meeting of DPSG

Mjesto i datum
Rim, Italija, 25.09.2009. - 28.09.2009

Vrsta sudjelovanja
Poster

Vrsta recenzije
Nije recenziran

Ključne riječi
efficacy; safety; insulin; detemir; NPH; type 1 diabetes mellitus

Sažetak
Background. In recent years, the basal insulin analogue Detemir has been introduced. It is developed to improve upon the limitations of Neutral Protamine Hagedorn insulin (NPH) and other conventional basal insulins, which have an inadequate duration of action, a marked peak glucose-lowering effect and variability in response from one injection to another. Detemir might help to overcome some of the barriers to insulin initiation and optimization, including concerns over hypoglycemia and weight gain. The efficacy and safety of insulin Detemir (Levemir®), a long-acting human insulin analogue plus insulin aspartat, were compared with NPH plus insulin aspartat for pregnant women with type-i diabetes mellitus (DM-i). Methods. In a randomized, parallel-group, open-labeled trial, 28 women with uncomplicated DM-1 (age 30.3 ± 4.6 years, HbA1c < 7%) were randomized to receive Detemir (2X daily) plus insulin aspartat (I. group ; n=14) and NPH (2X daily) plus insulin aspartat (II. group ; n=14). The trial period extended from first trimester (from 6-10 weeks) to 6 weeks postpartum. Results. Both treatment groups maintained good overall glycemic control during the study. At beginning of the study HbA1c did not differ between two groups: 6.56 ± 0.83:6.82 ± 0.58 ; n.s.). At the end of the study we found statistically significant decrease in HbA1c in I. group of patients (5.8 ± 0.74 : 6.4 ± 0.96 ; p<0.05). No major hypoglycemic events were reported during the study in both groups. The mean postprandial glucose concentrations in the I. group were lower than in the II. group (5.66 ± 1.o3 mmol/: 6.24 ± 1.31 mmol/L). Newborns weight did not differ between two groups (3286.25 ± 443g : 3114 ± 626.o8g). Two deliveries were preterm in both groups (at 35th and 36th weeks of pregnancy) and 26 deliveries were at term (> 38th weeks of pregnancy), and newborns were healthy. Conclusion. Detemir was more effective than NPH in decreasing postprandial glucose concentrations. Overall safety and effectiveness of Detemir were comparable to NPH in pregnant women with DM-1.

Izvorni jezik
Engleski

Znanstvena područja
Kliničke medicinske znanosti

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