|June 08, 2005|
|One of the largest prospective treatment trials of diabetes management ever undertaken revealed once-daily Lantus® (insulin glargine [rDNA origin] injection) was effective in lowering blood sugar levels in type 2 patients with long-standing poorly controlled diabetes|
A just-published global study of nearly 5,000 people with type 2 diabetes demonstrated that treatment regimens that included the 24-hour basal insulin Lantus® significantly improved glycemic (blood sugar) control with a low risk of severe hypoglycemia (low blood sugar). Results appear in the June 2005 issue of Diabetes Care, a medical journal published by the American Diabetes Association.
“This study provides important new information on current diabetes treatment patterns and confirms that the unique and predictable 24-hour profile of Lantus® facilitates patient self-titration in real-world clinical practice, with a low risk of severe hypoglycemia, normally a concern for doctors” said Melanie Davies, MD, Consultant in Diabetes, at the University Hospitals of Leicester, UK and the principal researcher of the study.
The study, called AT.LANTUS, (A Trial comparing Lantus® Algorithms to achieve Normal blood glucose Targets in patients with Uncontrolled blood Sugar) examined two different methods of titrating the dose of Lantus®. Titration is the process of starting and increasing the dose until a desired result of treatment is achieved – in this case, a predetermined reduction in fasting blood sugar levels. Both titration regimens were used to optimize glycemic control, including significant reductions in A1C and fasting blood sugar levels. Titration that was self-directed by patients produced significantly greater reductions in A1C and fasting blood sugar than titration performed during physician office visits. Participants had type 2 diabetes for an average duration of 12.3 years and an average A1C of 8.9% at baseline; 72% were already on some form of insulin therapy before starting Lantus®. By study’s end, Lantus®-treated patients had statistically significant decreases in A1C (>1%) and FBG from baseline values. Basal therapy uses a long-acting insulin to control blood sugar throughout the day and night; it may be used in conjunction with oral antidiabetic therapy and/or shorter-acting insulin at mealtimes.
In clinical practice, patients with type 2 diabetes do not routinely reach treatment targets despite the use of insulin and/or oral antidiabetic medications. An estimated 57% of people with type 2 diabetes (nearly 6.3 million Americans) undergoing treatment have an A1C – a blood test that measures blood glucose levels over a two-to-three month period – that is higher than 7%, the level recommended by the American Diabetes Association. A1C, also referred to as glycated hemoglobin or HbA1c, is the preferred standard blood test for assessing and monitoring glucose control in people with type 1 and type 2 diabetes. Prominent landmark studies – the United Kingdom Prospective Diabetes Study (UKPDS) and the Diabetes Complications and Control Trial (DCCT) – have shown that reduction in A1C is associated with a reduced risk for microvascular complications (small blood vessel complications that result in eye, kidney and nerve damage) and macrovascular complications (that result in cardiovascular events such as heart attack and stroke).
About the AT.LANTUS Trial
Participants were randomized to one of two Lantus® treatment regimens to be followed for 24 weeks. One regimen, based on clinic visits, raised the dose of Lantus® by 2-8 IU increments (with a starting dose of 10 IU for insulin-naïve patients). The other algorithm, facilitated self-titration by patients, added 2 IU of Lantus® every 3 days until the recommended FBG target was reached (with the first dose based on FBG for insulin-naïve patients). Patients adjusted the dose themselves, and had regular clinic visits by telephone or in-person under the supervision of an investigator.
About Lantus® (insulin glargine [rDNA origin] injection)
Lantus® is contraindicated in patients hypersensitive to insulin glargine or the excipients.
Hypoglycemia is the most common adverse effect of insulin, including Lantus®. As with all insulins, the timing of hypoglycemia may differ among various insulin formulations. Glucose monitoring is recommended for all patients with diabetes. Any change of insulin type and/or regimen should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may need to be adjusted.
Other adverse events commonly associated with Lantus® include the following: lipodystrophy, skin reactions (such as injection-site reaction, pruritus, rash), and allergic reactions.
For additional information, please visit: www.lantus.com.
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