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 (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-naïve 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-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.

Key words: :

• Biphasic insulin aspart
• Observational study
• Premixed insulin formulation
• Type 2 diabetes

Transparency

Declaration of funding

The IMPROVE study was funded by Novo Nordisk A/S, Denmark.

Declaration of financial/other relationships

P.V. has declared that he has served as chairman to the advisory board and has given lectures for, and received a research grant from, Novo Nordisk. J.G. and R.L. have disclosed that they have participated in advisory boards and in speakers’ bureaus for Novo Nordisk. M.B., V.B., R.K., J.S., S.S., M.S. and Y.W. have no significant relationships with or financial interests in any commercial companies related to this study or article.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgement

Writing and editorial assistance was provided by Dr Elien Moës and Dr Eva Cyhlarova, Watermeadow Medical UK, which was financed by Novo Nordisk.

A subset of the data presented here was published in poster form at the 44th Annual Meeting of the European Association for the Study of Diabetes, 7–11 September 2008, Rome, Italy (Kawamori R, Srishyla MV, Wenying Y: Better glycaemic control for 30,171 insulin-naïve patients with type 2 diabetes after starting biphasic insulin aspart 30/70 (BIAsp 30) therapy: IMPROVE™ study subgroup analysis).

Notes

* Novo Nordisk A/S, Bagsværd, Denmark.