Modern insulin approved for pregnant w diabetes

NovoRapid® - the first modern insulin approved in New Zealand for pregnant women with diabetes

1 May 2007, New Zealand – NovoRapid® (insulin aspart (rys)) is the first and only rapid-acting modern insulin, or insulin analogue, to be approved and fully subsidised in New Zealand for pregnant women with diabetes.1,2

The announcement follows the largest ever trial of modern insulin in pregnant women with type 1 diabetes, lasting more than four years and involving 322 women.3 The trial, published this month in the international journal Diabetes Care, showed that NovoRapid® was as well tolerated and effective as human insulin, and may offer some benefits in terms of post-meal glucose control and preventing severe episodes of low blood sugar.

“Tight blood glucose control is very important for a good pregnancy outcome,” said Dr Janet Rowan, Obstetric Physician, Auckland City Hospital. “Any woman planning to conceive wants the best for their unborn child. NovoRapid is an approved and effective treatment option for women with diabetes - before, and throughout their pregnancy.”

If not well controlled, diabetes can be a major problem for women wishing to conceive, with studies showing that complications are significantly more common in women with diabetes than in the general population.4-8 Poor blood glucose control in pregnancy, especially in the early stages, has been linked to:4,5
- five times the rate of stillbirth (death in the womb after 22 weeks)
- four times the rate of death just before or after birth (stillbirths and death of infants up to seven days after birth)
- two to ten times the rate of major physical birth defects.

The trial showed that compared to human insulin, NovoRapid® showed a consistent trend towards improved outcomes. Although the differences were not statistically significant, they included:3
- better post-breakfast glucose control (in the first and third trimesters), and
- a 52% reduction in major episodes of low glucose during the night.

Cathy Wood, who has had diabetes for eight years, used NovoRapid® during her last pregnancy and has continued to use it since then.

“NovoRapid® helps give me confidence that my diabetes will be well controlled. I gave birth to a healthy baby without any complications and now I have a second one on the way,” said Cathy.

The trial also showed that women who used NovoRapid® were significantly more satisfied with their treatment, mostly due to higher numbers reporting treatment flexibility and a willingness to continue using NovoRapid®.

“This new pregnancy indication for NovoRapid® offers women reassurance at a potentially stressful time in their lives,” said Helen Snell, Diabetes Nurse Practitioner, Diabetes Lifestyle Centre, Palmerston North. “I would recommend that women with diabetes who are planning to conceive, visit their specialist for preconception care and discussion about an insulin regimen to help ensure the best possible pregnancy outcome,” she concluded.

ENDS

FOR FURTHER INFORMATION PLEASE REFER TO CONSUMER MEDICAL INFORMATION, WHICH IS AVAILABLE FROM WWW.NOVONORDISK.CO.NZ OR SPEAK TO YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Additional trial information:
A randomised, parallel-group, open-label, multinational trial comparing the safety and efficacy of insulin aspart (rys) (NovoRapid®) versus human insulin (Actrapid®), used in a multiple injection regimen, in the treatment of pregnant women with type 1 diabetes. The trial focused on maternal hypoglycaemia and pregnancy outcomes, involved 322 women and was conducted over more than four years.

About NovoRapid® (insulin aspart (rys))
NovoRapid® is a rapid-acting modern insulin, licensed in New Zealand for the treatment of insulin-requiring diabetes mellitus2. NovoRapid® has been developed for use immediately before or soon after a meal and is normally used in a basal/bolus combination regimen with an intermediate or long-acting insulin2. NovoRapid® has a faster onset and shorter duration of action than soluble human insulin2. NovoRapid® shows a considerable reduction in major nocturnal hypoglycaemia (72%)9 – the greatest worry for people with diabetes.10

NovoRapid® is administered subcutaneously by injection or with a pump. It is delivered through insulin delivery devices such as NovoPen® 3 and NovoPen® 3 Demi, which are easy to use and allow simple dose correction.11

NovoRapid® is fully subsidised under PHARMAC1 and is a registered trademark of Novo Nordisk A/S.

About Novo Nordisk
Novo Nordisk is a focused healthcare company with the broadest insulin product portfolio in the industry, and is the leading supplier of insulin in New Zealand. Novo Nordisk is a world leader in diabetes care and also 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 22,000 people in 69 countries and markets its products in 179 countries. For further company information visit www.novonordisk.co.nz

References:
1. PHARMAC Interactive Pharmaceutical Schedule: http://www.pharmac.govt.nz/interactive/scripts/search.asp?TYPE=beginning+with&GENERIC=Novo&search_type=schedule
2. NovoRapid® Product Information
3. Mathiesen ER, Kinsley B, Amiel SA et al. Maternal glycaemic control and hypoglycaemia in type 1 diabetic pregnancy. Diabetes Care 2007;30:771-776
4. Mary CM, Macintosh MC, Fleming KM et al. Perinatal mortality and congenital anomalies in the babies of women with type 1 and type 2 diabetes in England, Wales and Northern Ireland. BMJ 2006; 333:177
5. Casson IF, Clarke CA, Howard CV et al. Outcomes of pregnancy in insulin dependent diabetic women: results of a five year population cohort study. BMJ 1997; 315: 275-278
6. Hawthorne G, Robson S, Ryall EA et al. Prospective population based survey of outcome of pregnancy in diabetic women: results of the Northern Diabetic Pregnancy Audit 1994. BMJ 1997; 315: 279-281
7. Penney GC, Mair G, Perason DW; Scottish Diabetes in Pregnancy Group. Outcomes of pregnancy in women with type 1 diabetes in Scotland: a national population-based study. BJOG 2003; 110: 315-318
8. Hadden DR, Alexander A, McCance DR et al. Northern Ireland Diabetes Group, Ulster Obstetrical Society. Obstetric and diabetic care for pregnancy in diabetic women: 10 years outcome analysis, 1985-1995. Diabetic Med 2001; 18: 546-553
9. Heller S, Colagiuri S, Vaaler S et al. Hypoglycaemia with insulin aspart: a double blind, randomised, crossover trial in subjects with type 1 diabetes. Diabet Med 2004; 21(7): 769-775
10. Pramming S, Thorsteinsson B, Bendtson I et al. Symptomatic hypoglycaemia in 411 type 1 diabetic patients. Diabet Med 1991; 8(3): 217-222
11. Rex J, Jensen KH, Lawton, SA. A review of 20 years’ experience with the Novopen family of insulin injection devices. Clin Drug Invest. 2006; 26: 367-401

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