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Vienna, Austria - Data from a new study presented today at the annual meeting of the European Association for the Study of Diabetes (EASD) shows that type 2 diabetes patients starting insulin treatment with once-daily injection of NovoMix^® 30 (biphasic insulin aspart) achieve a significantly greater HbA_1c reduction compared to patients starting with a daily injection of insulin glargine. Treatment with NovoMix^® 30 also resulted in significantly lower blood glucose levels after dinner and at bedtime, as compared to insulin glargine. ¹

The new data is from the OnceMix study, which included 480 type 2 diabetes patients in 15 countries who were inadequately controlled with oral antidiabetic drugs. They were randomised to treatment with one daily injection of either NovoMix^® 30 or insulin glargine. A total of 433 completed the study. Mean reduction in HbA_1c from baseline to study completion at 26 weeks was -1.41% with NovoMix^® 30 and -1.25% with insulin glargine.¹

“The study shows that NovoMix^® 30 is a very effective option for type 2 diabetes patients who are to start on insulin,” said Professor Krzysztof Strojek from the Silesian Medical University in Zabrze, Poland, and lead author of the study. “An additional benefit of using a premixed insulin like NovoMix^® 30 from the start is that it is easy to intensify the treatment as diabetes progresses, which is both convenient for the patient and important for the long-term control of the disease.”

At the end of treatment, mean HbA_1c was 7.08% for NovoMix^® 30 and 7.23% for insulin glargine. When assessing postprandial glucose control, significantly lower plasma glucose levels were observed with NovoMix^® 30 after dinner and at bedtime (NovoMix^® 30 – insulin glargine = -0.52 mmol/l, 95% CI [-1.02; -0.03], p = 0.04) and (NovoMix^® 30 – insulin glargine = -0.78 mmol/l, 95% CI [-1.25; -0.31], p <0.01) respectively.¹

The incidence of hypoglycaemic episodes was very low with both treatments (6.5 episodes/year for NovoMix^® 30 and 4.8 episodes/year for insulin glargine, with three major hypoglycaemic episodes in each group) and the final daily dose was also low and similar with both NovoMix^® 30 and glargine (0.32±0.22 units/kg for NovoMix^® 30 and 0.29±0.19 units/kg for insulin glargine).¹

No clinically relevant differences between treatment groups were observed in cardiovascular risk markers, waist circumference, body weight or treatment satisfaction.

About OnceMix

The OnceMix study is a treat-to-target, randomised, parallel, multicentre and multinational open-label trial. The study took place in a wide range of patient populations in 15 countries worldwide and is the first head-to-head study between NovoMix^® 30 once daily and insulin glargine once daily.

During the four-week run-in period, titration of glimepiride and metformin was completed, followed by the randomisation and 26-week treatment period.

A total of 480 patients were randomised, of which 433 completed the trial and were included in the final analysis.

About NovoMix^® 30

NovoMix^® 30 (biphasic insulin aspart) is a premixed, dual-acting modern insulin indicated for the treatment of diabetes mellitus which contains both rapid-acting insulin (30%) and intermediate-acting insulin (70%). The rapid-acting component of NovoMix^® 30 begins to have an effect on glucose absorption within 0 to 10 minutes², so it can be taken right before a meal, compared to human insulin, which has to be given 15–30 minutes beforehand.

Adverse drug reactions observed in patients using NovoMix^® 30 products are mainly dose-dependent and due to the pharmacologic effect of insulin.² In patients with type 2 diabetes a meta-analysis showed that while risk of overall daytime hypoglycaemic episodes was increased in patients treated with NovoMix^® 30, it was associated with a reduced risk of overall nocturnal hypoglycaemic episodes and major hypoglycaemia compared to biphasic human insulin 30.²

Novo Nordisk is a healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 28,500 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For more information, visit novonordisk.com.

Further information:

References

[1] Franek E, et al. Once Daily Initiation with NovoMix 30 versus Insulin Glargine in Patients with Type 2 Diabetes Inadequately Controlled with Oral Drugs – a Randomized Controlled Trial. European Association for the Study of Diabetes 45^th Annual Meeting, Vienna, Austria, 29 September – 2 October 2009. Oral presentation no. 213

[2] NovoMix^® 30 Summary of Product Characteristics, July 2008.