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

Abstract

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.Methods:Patients in routine care who started insulin therapy with or switched to BIAsp 30 from existing insulin regimens were eligible for this 26-week study. This analysis includes only patients previously treated with basal insulin. Outcomes including adverse events, hypoglycaemic events and glycaemic profile were recorded from patients’ notes, recall and diaries.Results:Of the 748 patients included (age 59.7 ± 11.8 years, diabetes duration 11.4 ± 7.3 years, baseline HbA1c 9.1 ± 1.6%), 497 were previously using human neutral protamine Hagedorn (NPH) insulin and 245 analogue basal insulin. Overall, major and minor hypoglycaemia rates decreased from baseline to final visit (major: 0.171 to 0.011; minor: 9.70 to 5.89 events/patient-year) and were similar between the subgroups. HbA1c and fasting blood glucose were significantly reduced from baseline (NPH prestudy: −1.6%, −2.4 mmol/l; analogue basal prestudy: −1.8%, −2.4 mmol/l), as was postprandial blood glucose, with 33.8% of patients achieving the HbA1c target < 7% without hypoglycaemia. Insulin dose increased slightly from prestudy (0.33 ± 0.21 U/kg), baseline (0.40 ± 0.20 U/kg) to final visit (0.52 ± 0.26 U/kg); most patients (76%) followed a twice-daily regimen at final visit. Body weight did not change significantly and treatment satisfaction increased.Conclusions:Patients with type 2 diabetes inadequately controlled on basal insulins may improve their glycaemic control by intensification to BIAsp 30 therapy.

Cost-Effectiveness of Biphasic Insulin Aspart 30 VS. Human Premix Insulin in Type 2 Diabetes from the Payer's Perspective in Bulgaria

“…A modelling study was carried out based on real-life data of an observational study with biphasic insulin aspart 30, therapeutic patterns for Bulgaria and local cost data (8,12,16,20,21,24,28,30). (10,11,12,16,20).…”

“…in type 2 diabetes, intrapatient blood glucose variability is lower in modern insulins compared with older human insulins (3). A number of randomized and observational studies have demonstrated the safety and efficacy of biphasic insulin aspart 30 compared with biphasic human insulin (2,8,13,14,21,22,28,30). owing to the provided evidence, the international Diabetes Federation (iDF) recommended, along with other options, premixed insulin analogue regimens for the initiation of insulin therapy (9).…”

Early insulin therapy in patients with type 2 diabetes mellitus

“…28 Basal-bolus insulin therapy, though physiological, has the disadvantage of multiple injections. 29 Which of these insulin strategies is chosen depends on HbA1c level. In a newly diagnosed T2DM patient, if HbA1c is between 7% and 10% or it is 1% to 2% above the individualised target, and insulin therapy is indicated, bedtime basal insulin should be initiated together with metformin and sulfonylurea.…”

“…17,30 In a newly diagnosed T2DM patient, if HbA1c is greater than 10% or it is 2% above the individualised target, and insulin therapy is indicated, basal-bolus insulin therapy or biphasic premixed insulin therapy should be initiated together with metformin. 7,18,26,29,30 In a patient already on metformin and sulfonylurea, if HbA1c is between 7% and 10% or it is 1% to 2% above the individualised target, basal insulin may be added. If a patient is already on bedtime basal insulin plus oral agents and HbA1c is greater than 10% or it is 2% above the individualised target, it is best to discontinue sulfonylurea, continue metformin, and to introduce basal-bolus insulin therapy or biphasic premixed insulin therapy.…”

“…If a patient is already on bedtime basal insulin plus oral agents and HbA1c is greater than 10% or it is 2% above the individualised target, it is best to discontinue sulfonylurea, continue metformin, and to introduce basal-bolus insulin therapy or biphasic premixed insulin therapy. 7,18,26,29,30 Whichever insulin strategy is considered, fasting glucose, postprandial glucose and HbA1c should be assessed, and insulin therapy adjusted according to the individualised glycaemic target. The choice of insulin strategy must be discussed with the patient and agreed on to encourage adherence.…”