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Prospective Study Published in Diabetes Care Confirms Basal Therapy With Lantus(R) Improves Glycemic Control in Patients With Type 2 Diabetes Poorly Controlled on Prior Insulin Regimens

Posted on: Thursday, 9 June 2005, 09:00 CDT

BRIDGEWATER, N.J., June 9 /PRNewswire/ -- 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(R) 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(R) 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(R) Algorithms to achieve Normal blood glucose Targets in patients with Uncontrolled blood Sugar) examined two different methods of titrating the dose of Lantus(R). 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(R). By study's end, Lantus(R)-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

AT.LANTUS is a phase IV, multinational, multicenter, randomized, open study. The study population consisted of 4,961 patients with poorly controlled type 2 diabetes with baseline A1C level greater than 7% on various diabetes treatment regimens.

Participants were randomized to one of two Lantus(R) treatment regimens to be followed for 24 weeks. One regimen, based on clinic visits, raised the dose of Lantus(R) 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(R) 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.

Clinical Outcomes

-- Patients who self-titrated Lantus(R) showed significant additional

reductions in A1C and FBG, compared to patients whose titration was

managed during clinic visits.

-- There was no significant difference between the two treatment

regimens in incidence of severe hypoglycemia.

-- Among patients previously treated with twice-daily premix

insulin, A1C levels significantly decreased after treatment with

once-daily Lantus(R) (alone or with prandial insulin and/or oral

diabetes medications), with a very low incidence of severe

hypoglycemia (2.2% or less).

-- Among patients previously treated only with once- or twice-daily NPH,

A1C levels significantly decreased after treatment with once-daily

Lantus(R) alone (by 0.8% and 0.9% for the first and second

algorithms, respectively).

-- Among patients poorly controlled on oral antidiabetic medication at

the start of the study, the addition of Lantus(R) to one or more oral

medications was associated with a reduction of at least 1.48% in A1C.

About Lantus(R) (insulin glargine [rDNA origin] injection)

Lantus(R) is indicated for once-daily subcutaneous administration in the treatment of adult patients with type 2 diabetes mellitus and for adult and pediatric patients (6 years of age and older) with type 1 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia. Lantus(R) demonstrates a consistent slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours.

LANTUS(R) MUST NOT BE DILUTED OR MIXED WITH ANY OTHER INSULIN OR SOLUTION. If mixed or diluted, the solution may become cloudy, and the onset of action/time to peak effect may be altered in an unpredictable manner.

Lantus(R) is contraindicated in patients hypersensitive to insulin glargine or the excipients.

Hypoglycemia is the most common adverse effect of insulin, including Lantus(R). 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(R) include the following: lipodystrophy, skin reactions (such as injection-site reaction, pruritus, rash), and allergic reactions.

For additional information, please visit: http://www.lantus.com/ .

About sanofi-aventis

Sanofi-aventis Group is the world's third largest pharmaceutical company, ranking number one in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine, and vaccines. The sanofi-aventis Group is listed in Paris (EURONEXT: SAN) and in New York

The sanofi-aventis Group conducts its business in the United States through its subsidiaries Sanofi-Synthelabo Inc., Aventis Pharmaceuticals Inc. and Sanofi Pasteur Inc.

U.S. Contacts: Terri Pedone

+1-908-243-6578, Terri.Pedone@sanofi-aventis.com

Amy Ba

+1-908-243-4261, Amy.Ba@sanofi-aventis.com

sanofi-aventis

CONTACT: Terri Pedone, +1-908-243-6578, Terri.Pedone@sanofi-aventis.com,or Amy Ba, +1-908-243-4261, Amy.Ba@sanofi-aventis.com, both of sanofi-aventis

Web site: http://www.sanofi-aventis.com/http://www.lantus.com/

Company News On-Call: http://www.prnewswire.com/comp/232375.html

Source: PRNewswire

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