Yang Wenying

An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: The A1chieve study

AIM The aim of A(1)chieve was to remedy the deficit of data on the efficacy and safety of insulin analogues in routine clinical care in less well-resourced/newly developed countries. METHODS A non-interventional, 6-month, observational study of 66,726 people with type 2 diabetes, both insulin users and non-insulin users, started on insulin detemir, insulin aspart or biphasic insulin aspart in 28 countries across four continents. RESULTS Baseline HbA(1c) (±SD) was poor: 9.5 ± 1.8%. At 6 months, improvement was -2.1 ± 1.7% in the entire cohort, and -2.2 ± 1.7% and -1.8 ± 1.7% for prior non-insulin users and insulin users. All three analogue therapies gave similar results, again independently of prior insulin use, but also from seven pre-specified country groupings. Overall, hypoglycaemia did not increase in those new to insulin, and fell in those switching insulins. There was no change in body weight (-0.1 ± 3.7 kg), while lipid profile and systolic blood pressure (-6.3 ± 17.1 mmHg) were improved. CONCLUSIONS Beginning insulin analogue therapy in people with type 2 diabetes and poor blood glucose control is associated with marked improvements in diverse aspects of vascular risk factor profile without evidence of clinically significant safety or tolerability problems.

Initiating insulin therapy with, or switching existing insulin therapy to, biphasic insulin aspart 30/70 (NovoMix® 30) in routine care: safety and effectiveness in patients with type 2 diabetes in the IMPROVE™ observational study

Aims:  The IMPROVE™ observational study evaluated the safety profile and effectiveness of biphasic insulin aspart 30/70 (BIAsp 30) in patients with type 2 diabetes in routine practice in 11 countries.

The IMPROVE™ study – a multinational, observational study in type 2 diabetes: baseline characteristics from eight national cohorts

Aims:  The IMPROVE™ study is a multinational, open‐label, non‐randomised, 26‐week observational study assessing the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) treatment in type 2 diabetes in routine clinical practice. The principal aims of this report were to characterise the baseline population and physicians’ treatment decisions.

Intensification to biphasic insulin aspart 30/70 (BIAsp 30, NovoMix 30) can improve glycaemic control in patients treated with basal insulins: a subgroup analysis of the IMPROVE observational study.

Aims:  The international IMPROVE™ observational study investigated the safety profile and effectiveness of biphasic insulin aspart 30/70 (BIAsp 30) in the routine treatment of patients with type 2 diabetes. We present analyses for the subgroup of patients who switched from basal insulin to BIAsp 30.

Safety and effectiveness of biphasic insulin aspart 30/70 (NovoMix® 30) when switching from human premix insulin in patients with type 2 diabetes : subgroup analysis from the 6-month IMPROVE™ observational study

Aims:  IMPROVE™ is an open‐label, multinational, non‐randomised, 26‐week observational study designed to evaluate the safety and effectiveness of biphasic insulin aspart 30 (BIAsp 30) in routine clinical practice. Here, we report data for patients switching to BIAsp 30 from human premixed insulin.

Improved glycaemic control with BIAsp 30 in insulin-naïve type 2 diabetes patients inadequately controlled on oral antidiabetics: subgroup analysis from the IMPROVE study

Abstract 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-naïve patients are reported. Changes in glycated haemoglobin (HbA1c), fasting blood glucose (FBG), postprandial blood glucose (PPBG), weight, dose, proportion of patients achieving HbA1c < 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-naïve patients were included; mean age 55.6 years, diabetes duration 7.3 years, baseline HbA1c 9.24%. Significant reductions were seen for HbA1c (−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 HbA1c < 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-naïve 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.

Predictors of achieving HbA1c <7% and no hypoglycaemia 6 months after initiation of biphasic insulin aspart 30 in patients with type 2 diabetes in the IMPROVE study

Abstract 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 HbA1c <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 HbA1c, shorter duration of diabetes and no incidence of hypoglycaemia up to 13 weeks prior to initiation are predictors of achieving HbA1c <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. Trial registration: ClinicalTrials.gov identifier: NCT00659282.

Predictors of postprandial blood glucose response to biphasic insulin analogue therapy.

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.