Background:Early initiation of insulin therapy has widely been associated with numerous benefits, including improved glycaemic control and reduced long-term risk of developing microvascular diseases. Biphasic insulins offer a convenient option for insulin initiation, addressing both basal and postprandial insulin requirements with one injection, making them relatively simple for patients to dose. Development of biphasic insulin aspart (BIAsp) has further offered improved postprandial glycaemic control and lower rates of nocturnal and major hypoglycaemia than biphasic human insulin.Methods:The safety and efficacy of the 30/70 rapid-acting/intermediate-acting formulation of BIAsp (BIAsp 30) in patients with type 2 diabetes was examined in the IMPROVE study, a 26-week, international, observational trial. In this subanalysis, baseline clinical factors that predicted treatment success, defined as HbA(1c) <7% (<53 mmol/mol) without experiencing hypoglycaemia after 26 weeks on BIAsp 30 therapy, were assessed.Results:The composite endpoint was defined for 44,010 (77%) patients from the total cohort of 57,478, and 28,696 of these were included in the statistical examination. The results of the analysis suggest that those with lower baseline HbA1c of <= 8% (<= 64 mmol/mol), shorter duration of diabetes at baseline (<5 years) and no incidence of major hypoglycaemia at 13 weeks, or minor hypoglycaemia at 4 weeks, before the beginning of the trial were more likely to achieve treatment success.Conclusion:Lower baseline HbA(1c), shorter duration of diabetes and no incidence of hypoglycaemia up to 13 weeks prior to initiation are predictors of achieving HbA(1c) <7% without hypoglycaemia with a BIAsp 30 regimen. These results suggest that it is easier to reach target without hypoglycaemia with BIAsp 30 when prescribed earlier. As this was an observational study, lack of control groups or randomisation, as well as varying clinical practices in study countries, potentially introduced bias.

Biphasic insulin aspart 30 (BIAsp 30) has been shown in randomised controlled trials and the IMPROVE™ observational study to reduce postprandial blood glucose (PPBG) – thought to be an independent risk factor for cardiovascular disease. We used multivariate regression analysis to identify predictors of PPBG reduction in the IMPROVE™ study. A total of 52,419 type 2 diabetes patients were enrolled in the IMPROVE™ study (pre-study therapy subgroups: no pharmaceutical therapy, n = 8966; oral antidiabetic drugs [OADs] only, n = 33,797; insulin ± OADs, n = 9568; missing information on pre-study therapy, n = 88). Mean change from baseline in PPBG (mean of three meals) in the global cohort was −6.3 mmol/L; reductions in subgroups were: no pharmaceutical therapy, −8.8 mmol/L; OADs only, −6.0 mmol/L; insulin ± OADs, −5.1 mmol/L. High baseline PPBG was consistently and strongly predictive of PPBG response; lower baseline HbA1c and body mass index, greater age and shorter diabetes duration were also significant predictors of PPBG change. The novel findings from this study indicate that most patients can be expected to achieve a PPBG response with BIAsp 30 irrespective of baseline characteristics or previous therapy with an expected larger PPBG reduction when baseline PPBG is higher.

PURPOSE:Understanding treatment satisfaction (TS) for diabetes is increasingly important as treatment options increase. This study examines treatment satisfaction with NovoMix® 30 in an observational study in patients with type 2 diabetes.METHODS:The DiabMedSat assesses Overall, Treatment Burden, Symptom and Efficacy Treatment Satisfaction. The impact of type of pretreatment variables on TS was examined by ANOVA at baseline and week 26. Satisfaction at week 26 was examined by t-test and effect size. Linear regression models examined impact of prior treatment factors (age, gender, duration of diabetes, type of prior treatment and diabetes-related comorbidities) and current treatment factors (weight gain, hypoglycemic events, reaching therapeutic goal) on TS.RESULTS:The data set comprised 17,488 persons. Prior treatment with insulin had a more positive impact on baseline satisfaction. At week 26, there were no differences between type of prior treatment groups in Overall, Symptoms and Burden TS. Current treatment with NovoMix 30 significantly improved TS. Regression analyses examining the combined effect of pretreatment factors and current treatment factors found that all factors except for age-impacted TS although the domains impacted varied.CONCLUSIONS:Patients treated with NovoMix 30 reported improved treatment satisfaction, and the improvement is considered clinically meaningful to patients.

Objective:The aim of this subanalysis of the IMPROVE study was to evaluate the safety and effectiveness of initiating biphasic insulin aspart 30/70 (BIAsp 30) in type 2 diabetes patients uncontrolled on oral antidiabetic drugs (OADs).Methods:IMPROVE is a 26-week, open-label, non-randomised, international observational study in type 2 diabetes patients prescribed BIAsp 30 in routine clinical practice. The total cohort comprised 52 419 patients from various pre-study therapies. Here results from the subgroup of previously insulin-naive patients are reported. Changes in glycated haemoglobin (HbA(1c)), fasting blood glucose (FBG), postprandial blood glucose (PPBG), weight, dose, proportion of patients achieving HbA(1c) <7.0%, and rates of major and minor hypoglycaemic events were recorded. Treatment satisfaction was assessed using a validated questionnaire.Results:A total of 29 160 insulin-naive patients were included; mean age 55.6 years, diabetes duration 7.3 years, baseline HbA(1c) 9.24%. Significant reductions were seen for HbA(1c) (-2.12%; p < 0.0001), FBG (-4.07 mmol/L; p < 0.0001) and PPBG after all meals (mean: -5.27 mmol/L; p < 0.0001); 39.2% of patients achieved HbA(1c) < 7.0% without hypoglycaemia. Better glycaemic control was seen in patients treated with BIAsp 30 twice-daily (BID) both at baseline and final visit, or BID at baseline and three-times daily at final visit, compared with other regimens. The rate of major hypoglycaemic events decreased significantly, while the rate of minor hypoglycaemic events increased. Better glycaemic control and a lower rate of minor hypoglycaemia were observed in patients using BIAsp 30 without OADs than with OADs. There was no clinically relevant change in weight (-0.07 kg; p < 0.0001). At final visit, 59.7% of patients were extremely/very satisfied with treatment, compared with 10.2% at baseline.Conclusions:This open-label, non-randomised, observational study demonstrated that initiating insulin therapy with BIAsp 30 significantly improved glycaemic control in insulin-naive patients previously poorly controlled on OADs. The rate of major hypoglycaemia was reduced and treatment satisfaction increased after initiation of BIAsp 30. Furthermore, better glycaemic control was achieved with BIAsp 30 without OAD compared to with OAD.

IMPROVE™ is a multi nationol open-label, observational study of 26 weeks of biphasic insulin aspart 30/70 (NovoMix® 30") in routine clinica! treatment of individuals with imadequately controlled type 2 diabetes, This analysis reports pooled safety and efficacy rcsults from patients enrolled in the study by 22 February 2008 in six countries [Canada (n=1557), China (n=21,725). India (n=16,587), Japan (n=2121), Poland (n =4101), and Russia (n=2027);global n=48.118].