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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

 Relationships (a) between post‐breakfast blood glucose excursion (ΔBG) at baseline and that just after titration of pre‐dinner biphasic insulin aspart 70/30 and (b) between baseline HbA1c levels (%) and changes in HbA1c levels (ΔHbA1C, %) at 24 weeks from baseline.
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f2:  Relationships (a) between post‐breakfast blood glucose excursion (ΔBG) at baseline and that just after titration of pre‐dinner biphasic insulin aspart 70/30 and (b) between baseline HbA1c levels (%) and changes in HbA1c levels (ΔHbA1C, %) at 24 weeks from baseline.

Mentions: Achieved HbA1c levels are shown in Figure 1a. At 8 weeks after the initiation of BIAsp 30, mean HbA1c level was significantly decreased (7.4 ± 1.2, vs 8.5 ± 1.5% at baseline; P < 0.05). At 16 weeks, mean HbA1c level had stabilized to 6.8 ± 1.0% (P < 0.01 vs baseline) and showed a tendency toward a slight decrease until 24 weeks (at 24 weeks, 6.6 ± 0.7%, P < 0.01 vs baseline). At 16 weeks, the rates of patients who achieved HbA1c levels of <7.0 and <6.5% were 68.2% (15/22) and 45.5% (10/22), respectively. At 24 weeks, 16 of 20 (80.0%) and 7 of 20 (35.0%) patients had achieved HbA1c levels of <7.0 and <6.5%, respectively. Reduction of the rate of patients achieving a HbA1c level of <6.5% at 24 weeks was a result of worsening of HbA1c level to ≥6.5% in two patients and a patient dropping out before 24‐week follow up, among 10 patients who achieved a HbA1c level of <6.5% at 16 weeks. When the patients were stratified according to baseline HbA1c levels of <8.0 or ≥8.0%, 87.5% (7/8) and 75.0% (9/12) of patients, respectively, had achieved HbA1c levels of <7.0% at 24 weeks. Further, 37.5% (3/8) and 33.3% (4/12) of patients with respective baseline HbA1c levels of <8.0 and ≥8.0% had achieved HbA1c levels of <6.5% at 24 weeks. The rates of patients who had achieved HbA1c levels of <7.0 and <6.5% as the final evaluations at 24 weeks were not influenced by baseline HbA1c levels. Figure 2b shows a strong linear correlation between baseline HbA1c levels and change in HbA1c levels from the baseline (ΔHbA1c) at 24 weeks in 20 patients (Figure 2b), showing that an even higher HbA1c level at baseline can be lowered sufficiently by the regimen of the present study.


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)

 Relationships (a) between post‐breakfast blood glucose excursion (ΔBG) at baseline and that just after titration of pre‐dinner biphasic insulin aspart 70/30 and (b) between baseline HbA1c levels (%) and changes in HbA1c levels (ΔHbA1C, %) at 24 weeks from baseline.
© Copyright Policy
Related In: Results  -  Collection

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

f2:  Relationships (a) between post‐breakfast blood glucose excursion (ΔBG) at baseline and that just after titration of pre‐dinner biphasic insulin aspart 70/30 and (b) between baseline HbA1c levels (%) and changes in HbA1c levels (ΔHbA1C, %) at 24 weeks from baseline.
Mentions: Achieved HbA1c levels are shown in Figure 1a. At 8 weeks after the initiation of BIAsp 30, mean HbA1c level was significantly decreased (7.4 ± 1.2, vs 8.5 ± 1.5% at baseline; P < 0.05). At 16 weeks, mean HbA1c level had stabilized to 6.8 ± 1.0% (P < 0.01 vs baseline) and showed a tendency toward a slight decrease until 24 weeks (at 24 weeks, 6.6 ± 0.7%, P < 0.01 vs baseline). At 16 weeks, the rates of patients who achieved HbA1c levels of <7.0 and <6.5% were 68.2% (15/22) and 45.5% (10/22), respectively. At 24 weeks, 16 of 20 (80.0%) and 7 of 20 (35.0%) patients had achieved HbA1c levels of <7.0 and <6.5%, respectively. Reduction of the rate of patients achieving a HbA1c level of <6.5% at 24 weeks was a result of worsening of HbA1c level to ≥6.5% in two patients and a patient dropping out before 24‐week follow up, among 10 patients who achieved a HbA1c level of <6.5% at 16 weeks. When the patients were stratified according to baseline HbA1c levels of <8.0 or ≥8.0%, 87.5% (7/8) and 75.0% (9/12) of patients, respectively, had achieved HbA1c levels of <7.0% at 24 weeks. Further, 37.5% (3/8) and 33.3% (4/12) of patients with respective baseline HbA1c levels of <8.0 and ≥8.0% had achieved HbA1c levels of <6.5% at 24 weeks. The rates of patients who had achieved HbA1c levels of <7.0 and <6.5% as the final evaluations at 24 weeks were not influenced by baseline HbA1c levels. Figure 2b shows a strong linear correlation between baseline HbA1c levels and change in HbA1c levels from the baseline (ΔHbA1c) at 24 weeks in 20 patients (Figure 2b), showing that an even higher HbA1c level at baseline can be lowered sufficiently by the regimen of the present study.

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