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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.

Narita T, Goto T, Suganuma Y, Hosoba M, Morii T, Sato T, Fujita H, Miura T, Shimotomai T, Yamada Y, Kakei M - J Diabetes Investig (2011)

Bottom Line: 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.No severe hypoglycemic episodes were recorded.Progression of retinopathy was observed in 3 of the 29 enrolled patients.   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).

View Article: PubMed Central - PubMed

Affiliation: Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo.

ABSTRACT

Unlabelled: 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.

Materials and 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).

No MeSH data available.


Related in: MedlinePlus

 Mean 8‐point self‐monitored blood glucose (BG) profiles at 0 week and just after pre‐dinner biphasic insulin aspart 70/30 (BIASp 30) titration (a) in patients with 2 h post‐breakfast BG after BIAsp 30 titration <200 mg/dL and (b) in patients with 2 h post‐breakfast BG after BIAsp 30 titration ≥200 mg/dL. AB, 2 hours post‐breakfast; AD, 2 h post‐dinner; AL, 2 h post‐lunch; BB, pre‐breakfast; BD, pre‐dinner; BL, pre‐lunch; BT, bed time. *P < 0.05; **P < 0.01 versus values at 0 week revealed by the Wilcoxon signed‐ranks test.
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f3:  Mean 8‐point self‐monitored blood glucose (BG) profiles at 0 week and just after pre‐dinner biphasic insulin aspart 70/30 (BIASp 30) titration (a) in patients with 2 h post‐breakfast BG after BIAsp 30 titration <200 mg/dL and (b) in patients with 2 h post‐breakfast BG after BIAsp 30 titration ≥200 mg/dL. AB, 2 hours post‐breakfast; AD, 2 h post‐dinner; AL, 2 h post‐lunch; BB, pre‐breakfast; BD, pre‐dinner; BL, pre‐lunch; BT, bed time. *P < 0.05; **P < 0.01 versus values at 0 week revealed by the Wilcoxon signed‐ranks test.

Mentions: The patients in the present study showed widely divergent post‐breakfast ΔBG (from −18 to 228 mg/dL) even after nearly ideal FBG levels had been established by BIAsp 30 titration (Fig. 2a). Therefore, clinical characteristics with or without optimal post‐breakfast ΔBG after titration were explored. Individual post‐breakfast ΔBG at baseline and after BIAsp 30 titration showed a strong correlation (Fig. 2a), indicating that the treatment might scarcely influence the individual post‐breakfast ΔBG pattern. Therefore, we divided the patients into two groups according to post‐breakfast SMBG levels after BIAsp 30 titration: Group A, <200 mg/dL; and Group B, ≥200 mg/dL (Table 2). Figure 3 shows the daily 8‐point SMBG profiles at baseline and after BIAsp 30 titration, indicating relatively flat BG profiles in Group A and ruggedness in Group B. Table 2 shows the clinical characteristics of both groups. Patients in Group B had a greater proportion of women, older age, longer duration of diabetes and higher post‐breakfast ΔBG both before and after BIAsp 30 titration. Despite the rugged daytime BG profiles, even after BIAsp 30 titration, HbA1c levels after BIAsp 30 treatment in Group B were not significantly higher compared with that in Group A (Table 2).


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.

Narita T, Goto T, Suganuma Y, Hosoba M, Morii T, Sato T, Fujita H, Miura T, Shimotomai T, Yamada Y, Kakei M - J Diabetes Investig (2011)

 Mean 8‐point self‐monitored blood glucose (BG) profiles at 0 week and just after pre‐dinner biphasic insulin aspart 70/30 (BIASp 30) titration (a) in patients with 2 h post‐breakfast BG after BIAsp 30 titration <200 mg/dL and (b) in patients with 2 h post‐breakfast BG after BIAsp 30 titration ≥200 mg/dL. AB, 2 hours post‐breakfast; AD, 2 h post‐dinner; AL, 2 h post‐lunch; BB, pre‐breakfast; BD, pre‐dinner; BL, pre‐lunch; BT, bed time. *P < 0.05; **P < 0.01 versus values at 0 week revealed by the Wilcoxon signed‐ranks test.
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Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4008017&req=5

f3:  Mean 8‐point self‐monitored blood glucose (BG) profiles at 0 week and just after pre‐dinner biphasic insulin aspart 70/30 (BIASp 30) titration (a) in patients with 2 h post‐breakfast BG after BIAsp 30 titration <200 mg/dL and (b) in patients with 2 h post‐breakfast BG after BIAsp 30 titration ≥200 mg/dL. AB, 2 hours post‐breakfast; AD, 2 h post‐dinner; AL, 2 h post‐lunch; BB, pre‐breakfast; BD, pre‐dinner; BL, pre‐lunch; BT, bed time. *P < 0.05; **P < 0.01 versus values at 0 week revealed by the Wilcoxon signed‐ranks test.
Mentions: The patients in the present study showed widely divergent post‐breakfast ΔBG (from −18 to 228 mg/dL) even after nearly ideal FBG levels had been established by BIAsp 30 titration (Fig. 2a). Therefore, clinical characteristics with or without optimal post‐breakfast ΔBG after titration were explored. Individual post‐breakfast ΔBG at baseline and after BIAsp 30 titration showed a strong correlation (Fig. 2a), indicating that the treatment might scarcely influence the individual post‐breakfast ΔBG pattern. Therefore, we divided the patients into two groups according to post‐breakfast SMBG levels after BIAsp 30 titration: Group A, <200 mg/dL; and Group B, ≥200 mg/dL (Table 2). Figure 3 shows the daily 8‐point SMBG profiles at baseline and after BIAsp 30 titration, indicating relatively flat BG profiles in Group A and ruggedness in Group B. Table 2 shows the clinical characteristics of both groups. Patients in Group B had a greater proportion of women, older age, longer duration of diabetes and higher post‐breakfast ΔBG both before and after BIAsp 30 titration. Despite the rugged daytime BG profiles, even after BIAsp 30 titration, HbA1c levels after BIAsp 30 treatment in Group B were not significantly higher compared with that in Group A (Table 2).

Bottom Line: 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.No severe hypoglycemic episodes were recorded.Progression of retinopathy was observed in 3 of the 29 enrolled patients.   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).

View Article: PubMed Central - PubMed

Affiliation: Department of Endocrinology, Diabetes and Geriatric Medicine, Akita University Graduate School of Medicine, Hondo.

ABSTRACT

Unlabelled: 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.

Materials and 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).

No MeSH data available.


Related in: MedlinePlus