Study in type 2 diabetes shows low rates of hypoglycaemia and significant improvements in blood glucose control with insulin analogue treatment

New data from the A1chieve® study, published today in the journal Diabetes Research and Clinical Practice, show that type 2 diabetes patients can significantly improve their blood glucose control with a low occurrence of low blood sugar (hypoglycaemia). The study showed that before treatment with a Novo Nordisk insulin analogue was initiated, the average blood glucose control (HbA1c) among the 66,726 study participants was 9.5%, which is well above the internationally recognised target of 7%.

Poor blood glucose control puts people at high risk of developing diabetes-related complications; in this study up to 80% of people had diabetes complications and 75% already had cardiovascular diseases. After 24 weeks of treatment with a Novo Nordisk insulin analogue there was a significant reduction in HbA1c levels of 2.1%, from 9.5% to 7.4%.1 Reported rates of overall hypoglycaemia slightly increased in those new to insulin and fell in those who switched from other insulin therapies.1 Furthermore, patients reported quality of life improved significantly.2

Commenting on the data, Philip Home, Professor of Diabetes Medicine at Newcastle University, England said: “Improvements in HbA1c of this magnitude are of significant clinical importance. We know that every 1.0% reduction in HbA1c is associated with reducing the risk of long-term diabetes complications. Therefore, seeing improvements such as those we have seen in the study potentially mean a better longer term outlook for the people with diabetes involved”.3

A1chieve® is the largest study ever into the safety and effectiveness of insulin treatment and involves 66,726 people with type 2 diabetes from 28 countries across Asia, Africa, Europe and Latin America. Before entering into the study, people were started on one of three Novo Nordisk insulin analogue regimens based on their physician’s clinical judgement. The primary aim of the study was to evaluate the clinical safety of the study insulins in routine clinical practice, assessed by the incidence of serious adverse drug reactions (SADRs) including rates of major hypoglycaemia.

After 24 weeks, clinically meaningful improvements in overall blood glucose control were found with all three insulin analogue regimens:

• For people taking premix insulin NovoMix® 30, HbA1c decreased from 9.5% to 7.3% for insulin-naive (18,459 people) and from 9.4% to 7.5% for prior insulin users (8574 people).
• In people taking the long-acting insulin Levemir®, HbA1c decreased from 9.5% to 7.4% for insulin-naive (8,459 people) and from 9.3% to 7.6 % for prior insulin users (2,122 people).
• For people taking the fast-acting meal-time insulin NovoRapid® in combination with a basal insulin, HbA1c decreased from 10.1% to 7.3% for insulin-naive (1,127 people) and from 9.4% to 7.5% for prior insulin users (1,869 people).

Reported rates of overall hypoglycaemia slightly increased in those new to insulin, from 1.07 to 1.19 events/person/year, and fell in those who switched from other insulin therapies from 7.31 to 2.48 events/person/year.1 The total rate of reported SADRs after initiation of insulin analogues was 0.13 events/100 patient-years.

About the A1chieve® study4

A1chieve® is a global, prospective, observational, multi-centre, open-label, non-interventional, 24-week study evaluating adverse events and effectiveness of Novo Nordisk insulin analogues NovoMix® 30 (biphasic insulin aspart 30), Levemir® (insulin detemir) and NovoRapid® (insulin aspart) in 66,726 people with type 2 diabetes in near-routine, daily clinical practice in 28 countries across Asia, Africa, Europe and Latin America. The primary aim of the study is to assess the adverse event profile of the study insulins, including rates of hypoglycaemia. In addition, effectiveness (HbA1c, fasting plasma glucose, and postprandial plasma glucose) and patient quality of life outcomes were measured.

References

1. Home P, Naggar N E, Khamseh M et al. An observational non-interventional study of people with diabetes beginning or changed to insulin analogue therapy in non-Western countries: the A1chieve study. Diabetes Res Clin Pract 2011 in press
2. Shah S, Zilov A, Malek R et al. Improvements in quality of life associated with insulin analogue therapies in people with type 2 diabetes: results from the A1chieve observational study. Diabetes Res Clin Pract 2011 in press
3. The UKPDS Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998;352:837-53.
4. APROM ID# 3607 Date of approval November 2011
   Shah SN, Litwak L, Haddad J et al. The A1chieve study: a 60,000-person, global, prospective, observational study of basal, meal-time, and biphasic insulin analogs in daily clinical practice. Diabetes Res Clin Pract 2010 May;88 Suppl 1:S11-6.