Author/Editor		Mrevlje, Franc; Piletič, Miliovoj; Senčar-Božič, Petra
Title		Insulin Detemir izboljša glikemično urejenost in ima nevtralen učinek na telesno maso v slovenski kohorti raziskave Predictive - klinične izkušnje v Sloveniji
Translated title		Insulin Detemir improves glycemic control and is weight neutral in the Slovenian cohort of the Predictive study - clinical experience in Slovenija
Type		članek
Source		Zdrav Vestn
Vol. and No.		Letnik 77, št. 10
Publication year		2008
Volume		str. 699-705
Language		slo
Abstract		Background The PREDICTIVE™ study is a large, multinational, multi-centre, observational study assessing the safety and efficacy of insulin detemir in everyday clinical practice. Patients and methods The Slovenian cohort included 303 patients, with 268 (78 Type 1, 181 Type 2) patients eligible for the final analysis. The analysis was performed 12 weeks after switching the patients to insulin detemir, and evaluated: characteristics of the antidiabetic therapy (ATh; including OAD and number of daily injections), safety (total, severe and nocturnal hypoglycaemic events), efficacy (HbA1c and FBG levels, FBG variability), and effect on body weight. Results As for the ATh, the main shift was observed from premix regimens to more complex insulin regimens, and from OAD regimens to insulin therapy. Statistically significant reductions of total, severe and nocturnal hypoglycaemic events were observed in both groups (Type 1: from 4.4 %, 0.38 % and 1.11 % at the baseline to 1.8 %, 0.01 % and 0.24 % at the end; Type 2: from 2.3 %, 0.2 % and 0.89 % at the baseline to 0.7 %, 0.03 % and 0.2 % at the end, respectively; all p values < 0.001). Statistically significant reductions of HbA1c and FBG levels were also observed (Type 1: HbA1c from 8.11 % to 7.63 %, FBG from 8.9 mmol/L to 7.4 mmol/L; Type 2: HbA1c from 8.72 % to 8.06 %, FBG from 9.4 mmol/L to 8.0 mmol/L; all p values < 0.001). FBG variability (as measured by the average standard deviation) decreased from 2.33 mmol/L and 1.58 mmol/L to 1.86 mmol/L and 1.32 mmol/L in Type 1 and Type 2, respectively; both p values < 0.05). An overall trend toward weight loss was noted at week 12 (Type 1: ‐0.3 kg, NS; Type 2: ‐0.4 kg, p < 0.05). Conclusions The Slovenian cohort data thus support the short-term safety and efficacy of insulin detemir in daily clinical practice. These results are consistent with the findings of controlled clinical trials, including essentially no effect on body weight gain.
Descriptors		INSULIN DIABETES MELLITUS, NON-INSULIN-DEPENDENT DIABETES MELLITUS, INSULIN-DEPENDENT BODY WEIGHT HYPOGLYCEMIA HEMOGLOBIN A, GLYCOSYLATED COHORT STUDIES SLOVENIA