Six-month multicentric, open-label, randomized trial of twice-daily injections of biphasic insulin aspart 30 versus multiple daily injections of insulin aspart in Japanese type 2 diabetic patients (JDDM 11)

Hirao, Koichi; Arai, Keiko; Yamauchi, Mikio; Takagi, Hirofumi; Kobayashi, Masashi

doi:10.1016/j.diabres.2007.08.011

Cited by 40 publications

(60 citation statements)

References 19 publications

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“…This result was comparable to those obtained in previous reports, suggesting that glycemic control using a twice-daily injection regimen may be as effective as a multiple-daily injection regimen in insulinnaïve patients [11,12]. Furthermore, the twice-daily injection regimen achieved an equal glycemic control to that of the multiple-daily injection regimen even though the insulin dose was significantly lower.…”

Section: Discussionsupporting

confidence: 79%

“…Liebl et al [11] reported that twice-daily injections of premixed insulin analogue were as useful as multiple daily injections in insulinnaïve patients in the United States. Consistent with this finding, Hirao et al [12] recently reported that twice-daily injections of biphasic insulin aspart were as useful as multiple daily injections in insulin-naïve patients in Japan.…”

supporting

confidence: 65%

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Comparative Study of Effectiveness of Multiple-Daily Injections of Insulin Versus Twice-Daily Injections of Biphasic Insulin in Patients with Type 2 Diabetes

et al. 2009

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Abstract. To evaluate the efficacy of a multiple-daily injection regimen and a twice-daily injection regimen using biphasic insulin, we performed an observational study of 56 insulin-naïve patients with type 2 diabetes mellitus who began receiving insulin therapy while they were hospitalized. The subjects were divided into two groups: a multiple-daily injection group (n = 33), and a twice-daily injection group (n = 23). At baseline, the demographic and clinical characteristics were comparable between the two groups. The HbA1c levels were 10.0 ± 1.6% and 9.5 ± 2.2% (p = 0.36), respectively. At 12 weeks, the HbA1c levels decreased equally in the two groups (7.2 ± 1.8% in the multiple-daily injection group and 7.3 ± 1.6%, p = 0.80 in the twice-daily injection group). The baseline HbA1c, the duration of diabetes, and the endogenous insulin secretory capacity did not affect the change in HbA1c in either group. These results suggest that twice-daily insulin regimen using biphasic insulin is as effective and beneficial as multiple-daily injection regimen for the treatment in type 2 diabetic patients with very poor glycemic control and that in order to achieve the targeted glycemic goal, insulin therapy should be initiated at an early stage.

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Section: Discussionsupporting

confidence: 79%

supporting

confidence: 65%

Comparative Study of Effectiveness of Multiple-Daily Injections of Insulin Versus Twice-Daily Injections of Biphasic Insulin in Patients with Type 2 Diabetes

et al. 2009

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“…Although it is always necessary to exercise care when adjusting the insulin dose, and to pay attention to possible interactions with coadministered drugs, the characteristics of BIAsp 30 suggest that it may be possible to increase the dose slightly, and reduce HbA1c levels further without increasing the incidence of hypoglycemic episodes. Since several previous studies [13][14][15][16][17][18] , some of them were conducted in Japanese patients, have shown that BIAsp 30 improved HbA1c/daily glycemic profiles equally versus multiple insulin injection therapy or better than previous OAD therapy in insulinnaïve patients. Hypoglycemic episodes were not increased versus these regimens.…”

Section: Discussionmentioning

confidence: 99%

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

Yoshioka¹,

Kurihara²,

Manda³

et al. 2009

Diabetes Research and Clinical Practice

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The effectiveness of BIAsp 30 step-up therapy in achieving glycemic control in Japanese patients with type 2 diabetes mellitus was investigated. Study subjects were 99 patients with type 2 diabetes mellitus aged over 20 years who were judged to require insulin therapy due to poor glucose control (HbA1c level of ≥7.5%). BIAsp 30 dosage was determined by the patient's attending physician; co administration of hypotensive agents and antilipemic agents was permitted, but OAD co administration was limited to patients already receiving such drugs at the start of the study. Patients who did not achieve HbA1c <6.5% after 16±5 weeks with QD (Phase 1) were stepped up to BID (Phase 2). If patients still had not achieved HbA1c <6.5% after 16±5 weeks with BID, they were stepped up to TID (Phase 3). 55 of the 99 enrolled subjects completed the study and the rates of achievement of HbA1c<6.5% and HbA1c<7.0% were 45.5% and 74.5% respectively. Of all registered subjects, 5.1% (5/99) achieved HbA1c<6.5% in QD, 19.5% (16/82) in BID, and 20.6% (7/34) in TID. Statistically significant reductions in HbA1c levels were recorded at the conclusion of each phase, with no incidents requiring intervention, indicating that BIAsp 30 step-up therapy is a safe, simple therapy that can be useful in achieving better glycemic control for Japanese patients with type 2 diabetes mellitus.

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“…Three trials that recruited 740 insulin-naive patients with median follow-up of 6 months (6-12 months) compared biphasic with prandial insulin [36,37,53].…”

Section: Biphasic Vs Prandial Insulinmentioning

confidence: 99%

Optimal insulin regimens in type 2 diabetes mellitus: systematic review and meta-analyses

et al. 2009

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Aims/hypothesis We compared the effect of biphasic, basal or prandial insulin regimens on glucose control, clinical outcomes and adverse events in people with type 2 diabetes. Methods We searched the Cochrane Library, MEDLINE, EMBASE and major American and European conference abstracts for randomised controlled trials up to October 2008. A systematic review and meta-analyses were performed. Results Twenty-two trials that randomised 4,379 patients were included. Seven trials reported both starting insulin dose and titration schedules. Hypoglycaemia definitions and glucose targets varied. Meta-analyses were performed pooling data from insulin-naive patients. Greater HbA 1c reductions were seen with biphasic and prandial insulin, compared with basal insulin, of 0.45% (95% CI 0.19-0.70, p=0.0006) and 0.45% (95% CI 0.16-0.73, p=0.002), respectively, but with lesser reductions of fasting glucose of 0.93 mmol/l (95% CI 0.21-1.65, p = 0.01) and 2.20 mmol/l (95% CI 1.70-2.70, p<0.00001), respectively. Larger insulin doses at study end were reported in biphasic and prandial arms compared with basal arms. No studies found differences in major hypoglycaemic events, but minor hypoglycaemic events for prandial and biphasic insulin were inconsistently reported as either higher than or equivalent to basal insulin. Greater weight gain was seen with prandial compared with basal insulin (1.86 kg, 95% CI 0.80-2.92, p=0.0006). Conclusions/interpretation Greater HbA 1c reduction may be obtained in type 2 diabetes when insulin is initiated using biphasic or prandial insulin rather than a basal regimen, but with an unquantified risk of hypoglycaemia. Studies with longer follow-up are required to determine the clinical relevance of this finding.

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Six-month multicentric, open-label, randomized trial of twice-daily injections of biphasic insulin aspart 30 versus multiple daily injections of insulin aspart in Japanese type 2 diabetic patients (JDDM 11)

Cited by 40 publications

References 19 publications

Comparative Study of Effectiveness of Multiple-Daily Injections of Insulin Versus Twice-Daily Injections of Biphasic Insulin in Patients with Type 2 Diabetes

Comparative Study of Effectiveness of Multiple-Daily Injections of Insulin Versus Twice-Daily Injections of Biphasic Insulin in Patients with Type 2 Diabetes

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

Optimal insulin regimens in type 2 diabetes mellitus: systematic review and meta-analyses

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