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- Title
Quality of Life (QoL) Assessment of Insulin Detemir and NPH Human Insulin in Japanese Subjects with Diabetes on Basal-Bolus Regimen.
- Authors
Ishii, Hitoshi; Iwamoto, Yasuhiko; Kaku, Kohei; Kawamori, Ryuzo; Tajima, Naoko; Kobayashi, Masashi
- Abstract
This study assessed QoL in Japanese insulin requiring diabetic subjects on basal-bolus regimen with insulin detemir (IDet), a soluble basal insulin analog (n=196 type 1, 98 type 2), or NPH insulin (n=67 type 1, 35 type 2) during a 48-week trial where safety and efficacy were investigated. All subjects were adults with HbA[sub 1c] < 11%, BMI < 30 kg/m² and duration of diabetes ≥ 2 years, and on basal-bolus regimen ≥ 12 weeks. IDet or NPH was administered once or twice daily in combination with meal-related insulin aspart according to pre-tral treatment. A validated questionnaire consisting of insulin therapy related QoL at night (ITR-QOLN) and insulin treatment satisfaction questionnaire-Japan (ITSQ-J) were used at baseline, 24 weeks and end-of-trial. ITR-QOLN consists of 21 questions in 4 factors: anxiety before sleep (anxiety about nocturnal hypoglycemia before bedtime), disturbances during sleep (hypoglycemic disorder from bedtime to early morning), glycemic control before breakfast and well-being, while ITSQ-J includes 21 questions in 3 factors: flexibility, satisfaction and insulin delivery satisfaction. Data were analyzed using an ANOVA model with treatment group included as a fixed effect and the baseline as a covariate. Both in ITR-QOLN and ITSQ-J, all factors scored more favorably for IDet compared to NPH in type 1 diabetes subjects. Statistically significant differences were seen in total score and "anxiety before sleep" in ITR-QOLN as well as in total score and "satisfaction" in ITSQ-J. Due to the small sample size, no differences were seen in type 2 subjects. In conclusion, 48-week treatment of IDet provided favorable responses in QoL related insulin treatment questionnaire compared to NPH in type 1 patients, which may be due to the major characteristics of IDet: low within-subject variability in FPG, lower risk of hypoglycemia especially during the night and less weight gain.
- Subjects
JAPAN; QUALITY of life; INSULIN; DIABETES; HYPOGLYCEMIA; WEIGHT gain
- Publication
Diabetes, 2007, Vol 56, pA710
- ISSN
0012-1797
- Publication type
Article