Lantus® Add-on to Oral Monotherapy Therapy Showed Improved Glycemic Control in Type 2 Diabetes Patients Compared to Oral Actos Add-on to Oral Therapy
San Diego, CA
June 13, 2005
Late-breaking study at the American Diabetes Association’s (ADA) 65th Annual Scientific Session demonstrated Lantus® (insulin glargine [rDNA origin] injection) showed significant improvement in glycemic control vs pioglitazone after 48 weeks

The sanofi-aventis Group announced on June 11th  the results of a study which demonstrated that its basal insulin analog, Lantus®, when added to oral antidiabetes medicine, had significant reduction in A1C levels versus the oral thiazolidinedione Actos (pioglitazone) in adult patients with type 2 diabetes who were uncontrolled on oral monotherapy.  These findings were presented on Saturday, June 11th  at the American Diabetes Association’s 65th Annual Scientific Session in San Diego, CA.

“It has long been understood that the number of type 2 diabetes patients that have uncontrolled blood glucose on oral therapy is excessive,” said Luigi F. Meneghini, MD, Associate Professor of Clinical Medicine, Miller School of Medicine, University of Miami and Director, Kosow Diabetes Treatment Center and the principal investigator of the study.  “These results make a case for Lantus® as an early add-on therapy for adult patients with type 2 diabetes on sulfonylurea or metformin monotherapy who are not reaching the under 7% A1C goal.” 

The ADA recommends that people with diabetes achieve an A1C<7% for optimal diabetes control.  A1C, also referred to as glycated hemoglobin or HbA1c, is a measure of blood glucose levels over a two- to three-month period and is the preferred standard blood test for assessing and monitoring long-term glucose control in people with type 1 and type 2 diabetes.

The 48-week randomized, parallel group, two-arm, open label study, which was conducted in 173 type 2 diabetes patients at 60 U.S. sites, compared reductions in A1C levels in patients who were uncontrolled (defined as A1C between 8-12%) on sulfonylurea or metformin oral monotherapy.  After 48 weeks, the mean change in A1C was -2.6% for Lantus® compared to -2.3% for Actos, and the mean A1C for patients treated with Lantus® was 6.7% compared to 7.0% for Actos (p≤0.05).

In this study, the most common adverse events for Lantus® vs Actos (number of patients) were edema (1 vs 13), increased weight (6 vs 9), headache (0 vs 5) and hypoglycemia
(4 vs 1).

About Lantus® (insulin glargine [rDNA origin] injection) 
Lantus® is indicated for once-daily subcutaneous administration, at the same time each day, for the treatment of adult and pediatric patients (6 years and older) with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.

LANTUS® 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® 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.

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About sanofi-aventis

The 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 (NYSE: SNY).

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


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