Attainment of glycaemic goals in type 2 diabetes with once‐, twice‐, or thrice‐daily dosing with biphasic insulin aspart 70/30 (The 1‐2‐3 study)

Diabetes, Obesity and Metabolism - Tập 8 Số 1 - Trang 58-66 - 2006
Alan J. Garber1, Jack Wahlen2, Tyler S. Wahl3, Peter Bressler4, Rogelio Braceras5, Elsie Allen6,5, Rajeev Jain7
1Baylor College of Medicine, Houston, TX USA
2Endocrine Research Specialists, Ogden, UT, USA
3Internal Medicine Associates Research Center, Omaha, NE, USA
4Endocrine and Diabetes Associates, Dallas, TX, USA
5Novo Nordisk, Princeton, NJ, USA
6Current address: Bristol Myers Squibb, Princeton, NJ, USA.
7Milwaukee Medical Clinic, Advanced Healthcare, Milwaukee, WI, USA

Tóm tắt

Aim:  This observational study in patients with type 2 diabetes failing oral agent therapy with or without basal insulin was conducted to assess whether addition and self‐titration of biphasic insulin aspart 70/30 (BIAsp 30) could achieve American Association of Clinical Endocrinologists (AACE)/International Diabetes Federation (IDF) and American Diabetes Association (ADA) glycemic targets (HbA1c≤6.5 and <7%).Methods:  Enrolled patients (n = 100, HbA1c≥7.5 and ≤10%) were ≥18 years of age, had diabetes ≥12 months and had received a stable antidiabetic regimen for at least 3 months [minimum of two oral antidiabetic drugs (OADs) or at least one OAD plus once‐daily basal insulin ≤60 U]. Patients discontinued prior basal insulin and added one injection of BIAsp 30 (12 U or 70–100% of prior basal insulin dose within 15 min of dinner initiation). Patients self‐titrated their BIAsp 30 dose with investigator guidance every 3 or 4 days to achieve pre‐breakfast fasting blood glucose (FBG) of 80–110 mg/dl. At 16 weeks, a pre‐breakfast injection of 6 U of BIAsp 30 was added if week 15 HbA1c exceeded 6.5%; the added dose was titrated to achieve pre‐dinner BG of 80–110 mg/dl. After an additional 16 weeks, 3 U of pre‐lunch BIAsp 30 was added if HbA1c exceeded 6.5%. This added dose was adjusted based on 2‐h post‐lunch BG to achieve postprandial glucose of 100–140 mg/dl. Subjects achieving an HbA1c≤6.5% at 15 and 31 weeks completed the study at weeks 16 and 32 respectively.Results:  Addition of once‐daily BIAsp 30 before dinner enabled 21% of the patients to achieve AACE and IDF targets (HbA1c≤6.5%) and 41% to achieve ADA targets (HbA1c <7%). With two daily injections of BIAsp 30, these glycaemic goals were achieved by 52 and 70% of subjects. With three daily BIAsp 30 injections, 60% of patients achieved HbA1c≤6.5%, and 77% achieved HbA1c <7.0%.Conclusions:  This clinical trial demonstrates that initiation of once‐daily BIAsp 30 to type 2 diabetes patients poorly controlled on various OAD regimens was an effective treatment approach for achieving glycaemic goals. Additional patients safely achieved these goals by increasing the number of BIAsp 30 injections from one to two, and then, if uncontrolled, from two to three doses per day. Eventually, most patients previously uncontrolled on OADs with or without basal insulin were controlled by the addition and vigorous titration of BIAsp 30 to oral agent therapy.

Từ khóa


Tài liệu tham khảo

10.1016/S0140-6736(98)07019-6

American Diabetes Association., 2003, Implications of the United Kingdom Prospective Diabetes Study, Diabetes Care, 26, S28, 10.2337/diacare.26.2007.S28

10.2337/diacare.27.2007.S15

10.4158/EP.8.S1.40

10.2337/diab.44.8.968

10.1136/bmj.321.7258.405

2002, American College of Endocrinology Consensus Statement on Guidelines for Glycaemic Control, Endo Pract, 8, 1

American Association of Clinical Endocrinologists (AACE) website.Diabetes Guidelines.http://www.aace. com/clin/guidelines/diabetes_2002.pdf.

10.7326/0003-4819-141-6-200409210-00007

10.1007/s00125-002-0932-4

10.1001/archinte.161.3.397

10.1007/s001250050617

10.1038/sj.ijo.0802174

International Diabetes Federation Clinical Guidelines Task Force.Global guideline for type 2 diabetes. Retrieved September 14 2005 fromhttp://www.idf.org/home/index.cfm?unode=B7462CCB‐3A4C‐472C‐80E4‐710074D74AD3.

10.2337/diacare.20.10.1612

10.1016/S0149-2918(02)85129-3

10.2337/diacare.25.5.883

Declaration of Helsinki., 1997, Recommendations guiding medical physicians in biomedical research involving human subjects, JAMA, 277, 925, 10.1001/jama.1997.03540350075038

10.2337/diacare.26.3.881

10.2337/diacare.28.2.260

10.1016/j.clinthera.2004.12.015

10.2337/diacare.26.11.3080

Thông tin
Thông tin xuất bản

Diabetes, Obesity and Metabolism

Tập 8 Số 1

58-66

Thông tin tác giả