Zusammenfassung

BACKGROUND The PREDICTIVE™ study is a large, multinational, multi-centre, observational studyassessing 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 afterswitching the patients to insulin detemir, and evaluated: characteristics of the antidiabetictherapy (ATh; including OAD and number of daily injections), safety (total, severe andnocturnal hypoglycaemic events), efficacy (HbA1c and FBG levels, FBG variability), andeffect on body weight. RESULTS As for the ATh, the main shift was observed from premix regimens to more complex insulinregimens, and from OAD regimens to insulin therapy. Statistically significant reductionsof 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; Type2: 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 FBGlevels were also observed (Type 1: HbA1c from 8.11 % to 7.63 %, FBG from 8.9 mmol/Lto 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 1and Type 2, respectively; both p values < 0.05). An overall trend toward weight loss wasnoted 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 controlledclinical trials, including essentially no effect on body weight gain