Clinical Study Results Demonstrated Greater Flexibility With Mealtime Dosing of Apidra® When Compared to Regular Human Insulin
San Diego, CA
June 13, 2005
Study presented at the American Diabetes Association’s 65th Annual Scientific Session reaffirmed pre- and post-meal dosing of Apidra as effective as pre-meal RHI

The sanofi-aventis Group announced on June 11th  the results of a sub-analysis of a study demonstrating that its prandial insulin, Apidra® (insulin glulisine [rDNA origin] injection), when administered before, during or after meals, produced comparable glycemic control (as measured by reductions in A1C levels) as pre-meal administration of regular human insulin in the treatment of patients with type 1 diabetes.  These findings were presented on Saturday, June 11th  at the American Diabetes Association’s 65th Annual Scientific Session in San Diego, CA.

“There have been few studies examining the practice of post-meal prandial insulin administration, but because we know that many people with diabetes probably do administer insulin after eating, it is important to confirm that this can be done without compromising glycemic control,” said Satish Garg, MD, Chief, Young Adult Clinics, Professor of Pediatrics & Medicine, Barbara Davis Center for Diabetes, University of Colorado School of Medicine, Denver, and the principal investigator of the study.  “These results showed that post-meal Apidra was just as effective as pre-meal regular human insulin.”

In this open, multinational, randomized, controlled, parallel, 12-week study, type 1 diabetes patients received once-daily basal insulin, Lantus® (insulin glargine [rDNA origin] injection) in combination with either Apidra 0-15 minutes pre-meal, Apidra® immediately after meal completion, Apidra® 20 minutes after meal completion or regular human insulin 30-45 minutes pre-meal.  Baseline to endpoint changes in A1C were similar for post-meal Apidra® and regular human insulin (-0.11 vs. –0.13%), with comparable rates of severe hypoglycemic episodes (8.4 vs. 10.1%).  A statistically significantly greater proportion of patients decreased total insulin dose from baseline with both pre- and post-meal Apidra when compared to regular human insulin (46.1% and 46.4% vs. 32.7%; p=0.0014 and p=0.0008 respectively).

Severe hypoglycemic episodes were comparable for pre- and post-meal Apidra® vs. regular human insulin.

About APIDRA® (insulin glulisine [rDNA origin] injection) 
Apidra® is a rapid-acting man-made insulin that is like insulin made by your body.  Apidra® is used to treat adults with diabetes for the control of high blood sugar.  Apidra® is used with a longer-acting insulin or by itself as insulin pump therapy to maintain proper blood sugar control.  


You should not use Apidra® if you are having a low blood sugar reaction (hypoglycemia) or if you are allergic to insulin glulisine.  Apidra® differs from regular human insulin by its rapid onset of action and shorter duration of action. When used as a mealtime insulin, the dose of Apidra® should be given within 15 minutes before or immediately after a meal.  Because of the short duration of action of Apidra, patients with diabetes also require a longer-acting insulin or insulin infusion pump therapy to maintain adequate glucose control.  Any change of insulin should be made cautiously and only under medical supervision.  Other oral antidiabetic treatment may need to be adjusted.  Glucose monitoring is recommended for all patients with diabetes.  Possible side effects may include blood sugar levels that are too low (hypoglycemia); injection site reactions, including changes in fat tissue at the injection site; and allergic reactions, including itching and rash.  Less common but potentially more serious is generalized allergy to insulin.  Severe cases of generalized allergy, including anaphylactic reactions, may be life threatening.  Tell your doctor about all other medicines and supplements you are taking because they can change the way insulin works.

Please see accompanying additional important information.

About LANTUS® (insulin glargine [rDNA origin] injection) 
LANTUS® 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® demonstrates a consistent slow, prolonged absorption and a relatively constant concentration/time profile over 24 hours. 
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.   

Please see accompanying additional important information.


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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