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Insulin Initiation With NovoMix 30 (Biphasic Insulin Aspart) Yields Significantly Greater Blood Glucose Reductions than Basal Insulin

New data released at the 196^th Meeting of the Society for Endocrinology today

LONDON, UK -- November 7, 2005 -- Initiating insulin therapy with NovoMix^® 30 (biphasic insulin aspart) plus metformin in patients achieving insufficient glycaemic control on oral antidiabetics (OADs) resulted in significantly greater blood glucose reductions than initiating therapy with basal insulin (glargine) plus oral glimepiride, according to new data from the EuroMix trial presented at the 196^th Meeting of the Society for Endocrinology in the UK by Prof Dr Peter Kann of the University Hospital Giessen and Marburg.

Controlling blood glucose levels is a key aspect of diabetes treatment and many of the serious health complications associated with diabetes, including an increased risk of cardiovascular disease, are a result of poor glycaemic control. Although it may be possible at first to maintain glycaemic control with diet and exercise and then OADs, it is likely that insulin will be required to achieve glycaemic targets at some stage. The trial examined and assessed starting insulin options that are currently available for GPs to help control glucose levels in their diabetes patients. The results demonstrated that NovoMix^® 30 is an effective tool for GPs to use to reduce blood glucose and help patients meet their goals in diabetes management.

In the randomised, open-label parallel-group trial, 255 patients (131 male; mean age 61.2 yrs) insufficiently controlled on OADs were randomised to 26 weeks' treatment with twice-daily NovoMix^® 30 plus metformin or once-daily glargine plus oral glimepiride.

The results showed that, at 26 weeks, patients in the NovoMix^® 30 group had a significantly greater reduction in haemoglobin A1c (HbA_1c), a key measure of blood glucose levels, compared to those in the glargine group (-0.51%; p = 0.0002). Absolute HbA_1c values after 26 weeks were also significantly lower in the NovoMix^® 30 group compared to the glargine group (7.5 vs. 7.9%; p = 0.01). The median total daily dose in the twice-daily NovoMix^® 30 plus metformin group was 25U and in the once-daily glargine plus oral glimepiride group, the median total daily dose was 28U.

"It is clear that type 2 diabetes patients who are failing to keep their blood glucose down to a safe level on OAD treatment can improve glycaemic control by starting insulin therapy. There is now a growing body of evidence showing that starting patients on biphasic insulin aspart may be a more effective option than glargine, and can help GPs to achieve glycaemic control in their patients," said Prof. Dr Kann. "The results of this trial are consistent with the INITIATE trial¹, which also showed that patients starting on biphasic insulin aspart achieved better glycaemic reductions, and were more likely to reach glycaemic targets than patients starting on glargine."

NovoMix^® 30 is effective at reducing HbA_1c levels because it contains both rapid- and intermediate-acting insulin to provide a fast response to glucose 'spikes' that occur after a meal, but also to give control throughout the day. In this way, HbA_1c levels are reduced markedly^1,2, glycaemic control is achieved using the same insulin in the same simple FlexPen^® device³, and treatment can be intensified if necessary by increasing treatment administration to three times a day.

The trial also demonstrated that both treatment regimens were safe, with just one major hypoglycaemic event in each study group. During the same period, 20% and 9% of patients in the NovoMix^® 30 and glargine groups respectively experienced minor hypoglycaemic episodes. The results also showed that, during the trial, patients in the glargine plus glimepiride group experienced a significant mean weight increase of 1.5 kg, compared to a non-significant mean weight increase of 0.7kg in the NovoMix^® 30 plus metformin group.

REFERENCES:
1. Raskin P, et al: Initiating insulin therapy in type 2 diabetes. Diabetes Care 28:260-65, 2005.
2. Jain R, et al: Efficacy of biphasic insulin aspart 70/30 in patients with T2DM not achieving glycemic targets on OADs with/without basal insulin therapy. Diabetes 2005; 54(Suppl 1): A69.
3. Lawton S and Berg B: Comparative evaluation of FlexPen®, a new prefilled insulin delivery system, among patients and healthcare professionals. Diabetes 2001; 50(Suppl 2): A440.


SOURCE: Novo Nordisk

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