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Newly Published Study Results Showed That Two Mealtime Insulin Dosing Algorithms Were Effective for Patients with Type 2 Diabetes
Date:7/22/2008

Two Regimens Including Lantus(R) and Apidra(R) Resulted in Significant Reductions in A1C in Patients with Type 2 Diabetes, Whatever the Algorithm

Used

BRIDGEWATER, N.J., July 22 /PRNewswire/ -- Results from the "Adjust to Target in Type 2 Diabetes: Comparison of a Simple Algorithm to Carbohydrate Counting for Adjustment of Mealtime Insulin Glulisine" study, were published in the American Diabetes Association's (ADA) medical journal, Diabetes Care. This study, using a basal-bolus insulin regimen with Lantus(R) (insulin glargine [rDNA origin] injection) once daily (basal insulin) and rapid-acting Apidra(R) (insulin glulisine [rDNA origin] injection) at mealtime (bolus insulin) demonstrated significant reductions in postprandial blood glucose and A1C using two different dosing algorithms.

The 24-week, multicenter, randomized, controlled study compared two algorithms for adjusting mealtime insulin (Apidra(R)) in 273 intent-to-treat patients with type 2 diabetes. Apidra(R) and Lantus(R) were adjusted weekly in both groups based on the previous week's self-monitored blood glucose (SMBG) results. One group, the "Simplified Algorithm" group, was provided set doses of Apidra(R) to take before each meal. The second group, the "Carbohydrate Counting" group, was provided an insulin-to-carbohydrate ratio to use for each meal and adjusted their Apidra(R) dose based on amount of carbohydrate consumed. After 24 weeks, the percentage of patients who achieved A1C<7 percent -- the ADA's recommended target for blood sugar control -- while following these two treatment algorithms were 73% and 69% (P=0.70), respectively.

Average A1C levels at week 24 were 6.70 in the Simplified Algorithm group and 6.54 percent in the Carb Counting group. The respective mean A1C changes from baseline to 24 weeks were -1.46 percent and -1.59 percent (P=.24). A1C <7.0 percent was achieved by 73 percent (Simplified Algorithm) and 69 percent (Carb Counting) (P=.70); respective values for A1C <6.5 percent were 44.3 percent and 49.5 percent (P=.28). The Simplified Algorithm group had 53 episodes of severe hypoglycemia in 19 patients, and the Carb Counting group had 37 episodes in 19 patients, leading to estimates of 0.89 and 0.67 event/patient-year for the two groups (P=0.58). SMBG < 50 mg/dL with symptoms was slightly but statistically significantly more common in the Carb Counting group than in the Simplified Algorithm group (8.0 vs. 4.9 events/patient-year, P=0.02).

"A combination of basal and bolus insulin may be needed to achieve optimal glucose control in type 2 diabetes patients," explained study author Richard M. Bergenstal, MD, executive director, International Diabetes Center, Park Nicollet Health Services, Minneapolis, MN. "The simplified algorithm investigated in this study allowed patients to start with a fixed dose of Apidra(R) and then effectively adjust to target based on premeal glucose patterns, or to use carbohydrate counting, which involves a mathematical formula that helps patients match the size of their mealtime insulin dose with the amount of carbohydrates they eat. Having two effective options for managing mealtime insulin doses may increase patients' and clinicians' willingness to initiate basal-bolus therapy."

Throughout the study, SMBG levels were recorded before meals and at bedtime each day, as well as a 7-point blood glucose profile at weeks 2, 6, 12, 18, and 24 (endpoint). Blood glucose values at each visit declined in both arms, and the within-group change from baseline was statistically significant over all daily time points and study visits. By the study's conclusion, both arms significantly improved fasting plasma glucose (FPG) levels as well, with averages of 112.0 mg/dl in the Simplified Algorithm group and 101.8 mg/dl in the Carb Counting group (P<0.0001 for both groups).

"Type 2 diabetes is a progressive disease that requires treatment adjustments to help manage the potential risks that come with prolonged hyperglycemia," said Dr. Bergenstal. "The Adjust to Target trial demonstrated that basal-bolus insulin therapy may be an effective option for the many people with type 2 diabetes who are not achieving glycemic targets with their current insulin regimen."

About the Trial

Study participants were 28-71 years old, had type 2 diabetes for greater than or equal to 6 months and mean +/- SD A1C values of 8.1 +/- 0.9% (Simplified Algorithm) and 8.3 +/- 0.9% (Carb Counting Algorithm) at screening. They had taken greater than or equal to 2 insulin injections/day (36 percent on 2 injections, 64 percent on more than 2 injections) +/- metformin (one-third were on metformin), for greater than or equal to 3 months before study entry. Upon entry into the study, 37 percent were using Lantus(R) and at least one injection of a rapid-acting insulin analog, 36 percent were using a pre-mixed insulin and the remainder were on a combination of various other diabetes treatment regimens.

About Diabetes

Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin -- the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. More than 230 million people worldwide are living with the disease and this number is expected to rise to a staggering 350 million within 20 years. It is estimated more than 20 million Americans have diabetes, including an estimated 6.2 million who remain undiagnosed.

At the same time, more than 40 percent of those diagnosed are not achieving the blood sugar control target of A1C <7 percent recommended by the American Diabetes Association (ADA). The A1C test measures average blood glucose levels over a two- to three-month period.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

U.S. Media Contacts:

Carrie Melia

Carrie.Melia@sanofi-aventis.com

908-981-6486

US.GLA.08.06.085


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