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Step-up therapy with biphasic insulin aspart-70/30--Sapporo 1-2-3 study.

N Yoshioka¹, Y Kurihara, N Manda

¹Department of Medicine II, Hokkaido University Graduate School of Medicine, Kita 15 jyo, Nishi 7 cho-me, Kita-ku, Sapporo, Hokkaido, 060-8638, Japan. n-yoshi@med.hokudai.ac.jp

Diabetes Research and Clinical Practice

|May 12, 2009

Summary

BIAsp 30 step-up therapy effectively improved glycemic control in Japanese patients with type 2 diabetes. This safe and simple insulin regimen achieved target HbA1c levels in a significant portion of participants.

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Area of Science:

Endocrinology
Metabolic Diseases
Pharmacology

Background:

Type 2 diabetes mellitus (T2DM) remains a global health challenge, necessitating effective glycemic control strategies.
Suboptimal glucose management in T2DM can lead to severe long-term complications.
Insulin therapy is often required for patients with T2DM who do not achieve targets with oral agents.

Purpose of the Study:

To investigate the efficacy and safety of BIAsp 30 step-up therapy for glycemic control in Japanese patients with T2DM.
To evaluate the step-up approach from once-daily (QD) to twice-daily (BID) and thrice-daily (TID) BIAsp 30.
To assess the achievement of target HbA1c levels (<6.5% and <7.0%) with this therapeutic strategy.

Main Methods:

A prospective study involving 99 Japanese patients with T2DM and HbA1c ≥7.5% requiring insulin therapy.
Patients initiated on QD BIAsp 30, with step-up to BID and then TID if glycemic targets were not met.
Study duration was approximately 16 weeks per phase, with permitted coadministration of other agents.

Main Results:

Of 55 completers, 45.5% achieved HbA1c <6.5% and 74.5% achieved HbA1c <7.0%.
Overall, 5.1% achieved <6.5% with QD, 19.5% with BID, and 20.6% with TID.
Statistically significant reductions in HbA1c were observed at each phase, with no safety concerns.

Conclusions:

BIAsp 30 step-up therapy is a safe, simple, and effective strategy for improving glycemic control in Japanese patients with T2DM.
The step-up approach allows for individualized titration to achieve target HbA1c levels.
This regimen offers a viable option for managing T2DM in this patient population.