Efficacy and safety of patient-directed titration of once-daily pre-dinner premixed biphasic insulin aspart 70/30 injection in Japanese type 2 diabetic patients with oral antidiabetic drug failure: STEP-AKITA study.
Aims/Introduction:  To clarify clinical characteristics related to optimal glycemic control achieved after adding once-daily pre-dinner biphasic insulin aspart 70/30 (BIAsp 30) in Japanese type 2 diabetic (T2D) patients with oral antidiabetic drug (OAD) failure.


METHODS
Under this regimen, we evaluated changes in HbA1c levels and daily self-monitoring blood glucose (BG) profiles, as well as the incidences of hypoglycemia and retinopathy progression. The patients adjusted BIAsp 30 dosages themselves every 3-4 days according to a pre-determined algorithm to achieve fasting BG levels of 101-120 mg/dL. HbA1c levels were expressed as Japan Diabetes Society values.


RESULTS
Of 29 enrolled patients, 22 (HbA1c levels, 8.5 ± 1.5% [mean ± SD]) and 20 patients completed the 16- and 24-week follow-up, respectively. At 16 weeks 68.2 and 45.5%, and at 24 weeks 80.0 and 35% of patients had achieved HbA1c levels of <7.0 and <6.5%, respectively. The patients who had achieved optimal glycemic control, including daytime postprandial BG profiles after treatment, had lower post-breakfast BG excursions at baseline, shorter diabetes durations and younger age. No severe hypoglycemic episodes were recorded. Progression of retinopathy was observed in 3 of the 29 enrolled patients.


CONCLUSIONS
Lower post-breakfast BG excursions, shorter diabetes duration and younger age in Japanese T2D patients with OAD failure might warrant optimal glycemic control with safety after adding once-daily pre-dinner BIAsp 30 initiating regimen. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2010.00062.x, 2010).
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo.
Takuma
T
Narita
Akita Red Cross Hospital, Saruta, Kamikitate.
Takashi
T
Goto
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo ; Akita Red Cross Hospital, Saruta, Kamikitate.
Yumi
Y
Suganuma
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo ; Akita City Hospital, Kawamoto.
Mihoko
M
Hosoba
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo.
Tsukasa
T
Morii
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo.
Takehiro
T
Sato
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo.
Hiroki
H
Fujita
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo ; Akita City Hospital, Kawamoto.
Takeshi
T
Miura
Yokote Municipal Hospital, Yokote ; Akita Kumiai General Hospital, Ijima, Akita.
Takashi
T
Shimotomai
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo.
Yuichiro
Y
Yamada
Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo ; Department of Medicine, Saitama Medical Center, Jichi Medical University, Omiya, Saitama, Japan.
Masafumi
M
Kakei
Biphasic insulin aspart 70/30; Insulin initiation; Self‐adjusted treatment algorithm