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Once-daily Lantus (Insulin Glargine) Appears To Significantly Improve Blood Sugar Control: Presented at EASD

MUNICH, GERMANY -- September 8, 2004 -- Lantus® (insulin glargine [rDNA origin] injection), the unique once-daily basal insulin analogue, significantly improves blood glucose control compared to both pre-mixed insulin2 and previous therapy1, according to results of AT.LANTUS1 and LAPTOP2, announced today at the 40th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany. The LAPTOP study goes on to highlight that this improvement in blood glucose control was not achieved at the expense of hypoglycaemia, which was significantly reduced versus pre-mixed insulin, or at the risk of increased weight gain. The benefits seen with Lantus® in these two international randomised studies were reported in people with both type-1 and type-2 diabetes irrespective of whether they were using insulin for the first time or switching from another insulin formulation.

Professor Melanie Davies, Consultant in Diabetes, Head of Service, Metabolic Medicine at the University Hospitals of Leicester commented: "These results provide decisive evidence of the benefits of 24-hour, background insulin, in a wide ranging group of patients with both type-1 and
type-2 diabetes regardless of their previous insulin or tablet treatment."

Good or 'tight' control of blood glucose is essential in diabetes to reduce the risk of the development of long-term complications such as heart disease and stroke, eye disease (retinopathy), kidney disease (nephropathy), and nerve damage (neuropathy) that may result in foot ulcers and amputation. The standard for assessing diabetic control is A1C (also known as HbA1c or glycated haemoglobin), which provides a measure of the level of blood glucose control over two to three months. UK guidelines for both type-1 and type-2 diabetes recommend A1C targets of 6.5-7.5% depending on the individual patient's risk of long-term complications3,4, while in the US the ADA's Standards of Medical Care for Patients with Diabetes Mellitus11 define the treatment goal for A1c as <7%.

These targets are based on large studies5,6, which demonstrated that tight blood glucose control achieved by intensive treatment reduces the risk of long-term diabetic complications. However, in both studies, intensive treatment also significantly increased the risks of severe 'hypos' and weight gain. 'Hypos' are a concern for all patients with diabetes as in extreme cases they can lead to loss of consciousness or even a coma, while weight gain is a particular problem in people with type-2 diabetes, as gaining weight increases their resistance to insulin making their blood glucose more difficult to control7.

The body uses insulin to convert blood glucose into energy, however a person with diabetes is either unable to produce enough of their own insulin, or is not able to utilise it effectively when they can. According to Diabetes UK, there are about 1.4 million people in the UK with diabetes, though a further 1 million people may have the condition but are unaware of it8. In type-1 diabetes, the pancreas cannot produce any insulin, while in type-2 diabetes - which affects the majority of people with diabetes - the pancreas does not produce enough insulin and the body cannot use it effectively (insulin resistance).

Insulin replacement therapy is essential to control blood glucose in type-1 diabetes, but is also a necessary part of treatment in many people with type-2 diabetes, since the pancreas produces less and less insulin over time, even if patients receive oral treatment. Furthermore, recent evidence suggests as many as 59% of people with type-2 diabetes have an A1C greater than 7%9 and are therefore at an increased risk of developing long-term complications5,6.

There are two general categories of insulin: basal (background) insulin, designed to provide a continuous level of insulin similar to the slow, steady background secretion by the healthy pancreas, and bolus (meal) insulin, which corrects the high blood glucose that follows a meal or snack. LANTUS® is a basal insulin, but differs from other basal insulins as it is the first and only insulin analogue to be solely licensed for once a day administration for the treatment of diabetes in those of 6 years and above. It is also the only basal insulin analogue licensed for use in conjunction with oral hypoglycaemic agents, the benefits of which can be seen in the LAPTOP trial.

About AT.LANTUS and LAPTOP

AT.LANTUS (A Trial comparing Lantus Algorithms to achieve Normal blood glucose Targets in patients with Uncontrolled blood Sugar) was performed at more than 1,000 sites in 62 countries including the UK. It was a phase IIIb-IV multicentre, open study in which 7383 patients with poorly controlled diabetes (2426 with type-1 and 4947 with type-2) were randomised and started on LANTUS®, using two different algorithms for titrating the dose of LANTUS®. The two algorithms optimised glycaemic control, significantly reducing A1C compared to baseline. Furthermore, in the type-2 diabetes study, titration directed by the patients themselves produced significantly greater reductions in A1C than titration performed by healthcare professionals during clinic visits1.

According to AT.LANTUS investigator Professor Melanie Davies, Consultant in Diabetes, Head of Service, Metabolic Medicine at the University Hospitals of Leicester, "The AT.LANTUS data confirm that the unique and predictable 24-hour profile of Lantus® permits intensive, flexible titration without putting patients at unacceptable risk of hypoglycaemia. The study included a very large, diverse group of people with poorly-controlled diabetes, with all groups showing benefits from Lantus® therapy regardless of prior treatment options."

LAPTOP (Lantus® + Amaryl® + metformin vs. premixed* insulin in Patients with Type-2 diabetes mellitus after failing Oral treatment Pathways) was a 24-week multicentre, open, parallel-group study that included 364 people with type-2 diabetes recruited from centres in the UK, as well as Austria, Finland, France, Germany, Italy, the Netherlands, Spain, Sweden and Switzerland. None of the patients had ever received insulin and all had poor glycaemic control in spite of treatment with oral antidiabetic drugs (OADs). Patients were randomised to either Lantus® once daily while continuing oral therapy (Amaryl (glimepiride) + metformin), or discontinued OADs and received twice-daily premixed* injections2.

Fifty percent more patients in the Lantus® group achieved target A1C =7% without experiencing an episode of nocturnal hypoglycaemia, compared to those on premixed insulin and no OADs2. "These data confirm that adding basal insulin glargine to oral therapy can help physicians and their patients more safely and effectively restore glycaemic control in type-2 diabetes, with significantly less hypoglycaemia than twice-daily premixed insulin," said Hans Uwe Janka, M.D., the lead investigator and Professor of Medicine and head of section of internal medicine at the Centralhopital Bremen-Nord, Bremen, Germany. "With just one injection and one blood glucose measurement per day, this simple regimen is cost-effective and easy to initiate, particularly for older patients with type-2 diabetes. It's decisive evidence for physicians to start basal insulin in patients failing oral therapy."

Launched in the UK in 2002, Lantus® (insulin glargine [rDNA origin] injection) is indicated for the treatment of adults, adolescents and children of 6 years or above with diabetes mellitus, where treatment with insulin is required. It is administered subcutaneously once a day.

In its Technology Appraisal Guidance of 200210, the National Institute for Clinical Excellence recommended Lantus® for people with type-1 diabetes and people with type-2 diabetes who require insulin therapy and who fall into the following categories:
· Those who require assistance from a carer or health professional to administer their injection
· Those whose lifestyle is significantly restricted by recurrent symptomatic hypoglycaemic episodes
· Those who would otherwise need twice-daily basal insulin injections in combination with oral antidiabetic drugs.


References
1 Storms F, Shutler S, Rodriguez J, et al. The AT.LANTUS Trial investigating treatment algorithms for insulin glargine (LANTUS) therapy: results in patients with type 1 and type 2 diabetes. European Association for the Study of Diabetes, 40th Annual Meeting, 5-9 September, Munich, Germany
2 Janke H, Plewe G, Kliebe-Frisch C, et al. Starting insulin for type-2 diabetes with insulin glargine added to oral agents vs twice-daily premixed insulin alone. European Association for the Study of Diabetes, 40th Annual Meeting, 5-9 September, Munich, Germany
3 National Institute for Clinical Excellence. Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults. Clinical Guideline 15. London: National Institute for Clinical Excellence 2004
4 McIntosh A, Hutchinson A, Home P D, (2001) Clinical guidelines and evidence review for Type 2 diabetes: management of blood glucose. Sheffield: ScHARR, University of Sheffield 2001
5 Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1998; 329: 977-86
6 UK Prospective Diabetes Study (UKPDS) Group. Intensive blood glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes. Lancet 1998; 352: 837-53
7 International Diabetes Federation. Diabetes and cardiovascular disease: time to act. Brussels: International Diabetes Federation 2001
8 Diabetes UK. Diabetes UK-the missing million. Perceptions and reality of diabetes today. London: Diabetes UK 2000
9 NHS Tayside Diabetes Service Managed Clinical Network TDAG Annual Report. October 2002
10 National Institute for Clinical Excellence. Guidance on the use of long acting insulin analogues for the treatment of diabetes-insulin glargline. Technology Appraisal Guidance No 53. London: National Institute for Clinical Excellence: 2002
11 Standards of Medical Care for Patients with Diabetes Mellitus. American Diabetes Association Position Statement. Diabetes Care, Volume 25, Supplement 1 January 2002


SOURCE: Aventis

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