Bridgewater, NJ
June 13, 2005
Two studies show insulin glargine control of HbA1C in poorly controlled type 2 diabetes patients, with comparable rates of hypoglycemia

Data presented today at the 65th Session of the American Diabetes Association (ADA), San Diego, demonstrated that people with type 2 diabetes achieved significantly better glycemic control, and also achieved it earlier, when treated with the 24-hour basal insulin analog Lantus® (insulin glargine [rDNA origin] injection, sanofi-aventis) and their usual oral antidiabetes therapies* compared with patients receiving oral therapy alone, with comparable rates of hypoglycemia. Further data at the ADA show that Lantus® can be safely and effectively initiated in both primary and secondary care, to achieve their target glycemic control.

“These studies re-affirm that Lantus can help more people with type 2 diabetes reach their target blood sugar levels, and reach them earlier, so that introducing insulin glargine earlier in these patients may be beneficial. This data also highlights that Lantus can be titrated confidently and safely in both a primary and secondary care settings with comparable rates of  hypoglycemia,” commented Hertzel Gerstein and one of the investigators in the INSIGHT study.

The INSIGHT (Implementing New Strategies with Insulin Glargine for Hyperglycemia Therapy) study of 405 patients with type 2 diabetes for at least 6 months, demonstrated that earlier addition of insulin glargine to current diabetes therapy effectively reduced HbA1C levels significantly more than optimization of oral agents, and with comparable rates of hypoglycemia.  

During the study, patients received either addition of once daily insulin glargine (with no increase in oral antidiabetic therapy [OAD]), or were optimized on OAD therapy with no insulin. 

There were no differences in hypoglycemia noted between those receiving Lantus and those receiving oral agents.

The American Diabetes Association recommends that people with diabetes achieve an HbA1C <7% for optimal diabetes control, although more stringent glycemic goals (i.e. a normal HbA1C, <6%) may further reduce complications at the cost of increased risk of hypoglycemia. Other organizations, namely the European Diabetes Policy Group (EDPG) and the American Association of Clinical Endocrinologists (AACE), recommend a lower target of under 6.5%.  

In clinical practice, however, the majority of patients with type 2 diabetes do not routinely reach treatment targets. According to the National Health and Nutrition Examination Survey (NHANES IV) 1999-2000, only 37% of participants with previously diagnosed diabetes achieved the target HbA1C goal of less than 7.0%, and 37.2% of participants were above the “take action” HbA1C level of greater than 8.0%. These figures did not change significantly from those reported in NHANES III, which encompassed the years 1988 to 1994.

Another study, presented at the ADA, focusing on a sub-analysis of the AT.LANTUS trial in UK patients, further confirmed that Lantus® can be safely and effectively initiated in both primary and secondary care. The data highlighted that severe and nocturnal hypoglycemia rates are comparable between primary and secondary care managed patients (p=NS). 

The UK sub-analysis data are part of one of the largest prospective treatment trials of diabetes management ever undertaken - AT.LANTUS, (A Trial comparing Lantus® Algorithms to achieve Normal blood glucose Targets in patients with Uncontrolled blood Sugar) - published in the June 2005 issue of the ADA’s Diabetes Care journal. The global study of nearly 5,000 people from 59 countries with type 2 diabetes, demonstrated that a simple patient-administered titration algorithm with Lantus® significantly improves glycemic control with a low risk of severe hypoglycemia.

“We know from large, landmark studies that a reduction on HbA1C levels reduces the risk of a diabetic patient from developing both the micro and macrovascular complications of diabetes. With over half of the patients with type 2 diabetes failing to reach  their glycemic targets, the inclusion of Lantus  the first and only once-daily, insulin analog which may be used in combination with oral antidiabetes agents, provides an important approach to achieving better glycemic control,” commented Dr. Melanie Davies, Consultant in Diabetes at the University Hospitals of Leicester.

* 83.2% of patients received their usual OAD whereas 16.8% were treated only with lifestyle intervention

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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