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

Abstract

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.Methods:Patients (n=3856) with type 2 diabetes previously receiving human premixed insulin with or without oral antidiabetic drugs were eligible for inclusion. Demographic data, efficacy end-points (HbA1c, fasting blood glucose and postprandial blood glucose) and safety end-points (serious adverse drug reactions, hypoglycaemia and adverse events) were collected at baseline and final visit. A subgroup analysis of mean dose change was also undertaken.Results:Switching patients to BIAsp 30 resulted in significant improvements in glycaemic control combined with a reduced risk of hypoglycaemia. Patients who reached the HbA1c target (< 7%) had shorter diabetes duration, lower HbA1c at baseline and needed less insulin. Over 30% of patients were able to reach this target without experiencing hypoglycaemia over the 26-week period. Compared with asymmetric dose switching, unit-for-unit switching resulted in the highest proportion of patients reaching HbA1c target and incurred the least amount of dose titration.Conclusions:A unit-for-unit switch is the most effective as well as the simplest approach when transferring patients from biphasic human insulin 30 to BIAsp 30.

Are Analogue Insulins Superior to Human Insulin in Clinical Practice?

“…Rates of hypoglycemia were, unsurprisingly, increased in treatment-naïve subjects following introduction of insulin (minor hypoglycemia from 0.54 to 2.61 events/patient-year); however, switching to BIAsp 30 in the insulin-treated group resulted in a decrease in hypoglycemia (8.11 to 3.23 events/patientyear). Data from the subgroup of 3,856 subjects receiving human premixed insulin at baseline indicate that switching to biphasic analogue resulted in a 1.8% reduction in HbA 1c and a decrease in minor hypoglycemia from 7.7 to 2.0 events per patient per year [28]. Similar findings emerged from the PRESENT study, a large observational study in almost 22,000 patients with T2D.…”

Are insulin analogues an unavoidable necessity for the treatment of type 2 diabetes in developing countries? The case of Jordan

“…This finding is not inconsistent with Boehm et al's study, which reported that premixed insulin analogue was associated with a significantly lower incidence of major hypoglycaemia in comparison with premixed human insulin (6). Additionally, the IMPROVE study had also reported a reduction in hypoglycaemia upon shifting uncontrolled diabetes mellitus patients from premixed human insulin to premixed insulin analogue (10).…”

“…Although most clinical trials demonstrate at least equivalent efficacy of analogues relative to human insulin, with additional benefits in terms of better postprandial glycaemic control, flexible injection timing and improvement in adherence (6)(7)(8)(9)(10), many of these trials did not consider the ethnic variations and the difference in eating habits of the study population. For instance, people in the Middle East, including Jordanians, usually have 3 main meals a day, with a relatively high calorie intake at lunch.…”

An Internal Audit of Diabetes Care for Type 2 Diabetic Patients in a Public Hospital Diabetes Clinic in Malaysia

“…With shorter follow-up intervals of two to four weeks and faster and more effective titration of the insulin regime, the glycaemic control could be improved. Besides, modern insulin analogues that are premixed, such as Novormix or Humalog mix, should be considered for those diabetes patients with poor sugar control from human insulin, as they have been shown to provide better glycaemic control (14).…”