Effects of insulin changes on quality of life and glycemic control in Japanese patients with type 2 diabetes mellitus: The insulin-changing study intending to gain patients' insights into insulin treatment with patient-reported health outcomes in actual clinical treatments (INSIGHTs) study.
OBJECTIVE
Our primary objective was to assess changes in quality of life (QOL) associated with changes in insulin regimen in patients with type 2 diabetes mellitus. Secondary objectives were to assess the reasons for and patterns of changes in insulin regimen, and the effects on glycemic control.


METHODS
This 12-week, observational study included patients with type 2 diabetes mellitus (n = 625) who planned to change insulin regimen (type of insulin, injection device and/or number of injections). The primary outcome measure was a change from baseline in QOL assessed by the Insulin Therapy-Related (ITR) QOL questionnaire. The secondary outcome measures included change from baseline in plasma glycated hemoglobin (HbA1c) level, the reasons for and pattern of insulin regimen change, and change from baseline in QOL assessed by Diabetes Treatment Satisfaction Questionnaire (DTSQ).


RESULTS
QOL did not worsen during the study. Improvements were seen in the ITR-QOL 'daily activities' subscale score (baseline: 12.7 ± 2.3; week 12: 12.9 ± 2.3; P = 0.038, n = 568) and the DTSQ 'perceived frequency of hyperglycemia' subscale score (baseline: 3.4 ± 1.6; week 12: 3.0 ± 1.7; P < 0.001, n = 573). Glycemic control improved, as evidenced by decreased plasma HbA1c levels (baseline: 8.21 ± 1.47%; week 12: 7.85 ± 1.31%; P < 0.001, n = 606).


CONCLUSIONS
It was suggested that insulin regimen changes might improve glycemic control in Japanese patients with type 2 diabetes mellitus without worsening QOL. This trial was registered with ClinicalTrials.gov (no. NCT01055808).
Department of Endocrinology Tenri Hospital Nara Japan.
Hitoshi
H
Ishii
Department of Endocrinology and Metabolism Yokohama City University Graduate School of Medicine Yokohama Japan.
Yasuo
Y
Terauchi
Jinnouchi Hospital Kumamoto Japan.
Hideaki
H
Jinnouchi
Eli Lilly Japan K.K. Kobe Japan.
Masanori
M
Taketsuna
Eli Lilly Japan K.K. Kobe Japan.
Masakazu
M
Takeuchi
Eli Lilly Japan K.K. Kobe Japan.
Takeshi
T
Imaoka
Glycated hemoglobin; Insulin therapy‐related quality of life questionnaire; Type 2 diabetes mellitus