Aventis Launches Ground-Breaking Study, “Goal A1c” with 14,000 Type 2 Diabetes Patients

Purpose of study is to help doctors and patients find ways to manage diabetes more effectively. 

Aventis Pharmaceuticals, the US division of Germany’s Aventis Pharma group, has launched GOAL A1C, a large-scale trial designed to provide ground-breaking information about the management and care of people with diabetes.  

The program will enroll more than 14,000 type 2 diabetes patients in 3,500 primary care physicians’ offices, and was inspired by a number of emerging issues related to diabetes and its management, the company said. “We are seeing diabetes rise to epidemic proportions and patients experience complications at an alarming rate,” said Michael Pfeifer, medical product leader at Aventis Pharmaceuticals. “These trends tell us that we need to help doctors and patients find ways to manage diabetes more effectively. As one of the largest trials of its kind, GOAL A1C is designed to help us understand not only what we are doing well, but where we need to improve if we are to reverse the tide of this devastating disease.”

A1cnow is partnering with Aventis to provide the necessary A1c tests.

Diabetes Care 2002;25:417-424 

This study is a the result of 3 other studies in Europe, A trio of community based clinical studies show that diabetes patients who added LantusÒ (insulin glargine) to their daily oral medications, or who switched to Lantus from other insulin preparations, experienced significant reductions in blood sugar levels while either maintaining -- or actually losing -- weight. Data from these studies were presented  at the 62nd Scientific Sessions of the American Diabetes Association (ADA). 

The first study evaluated 389 patients (167 type 1; 222 type 2) who either replaced their prior insulin treatments with Lantus, or who initiated Lantus in addition to their current oral medications. After six months, a reduction in HbA1c of .65 percent was seen in type 1 patients (167) who had replaced their previous basal insulin with Lantus; a .79 percent reduction was seen in type 2 patients (208) who replaced their bedtime insulin with Lantus; and a 1.7 percent HbA1c reduction was observed in type 2 patients (14) who initiated insulin treatment with Lantus in addition to current oral treatments. Furthermore, these blood sugar reductions with Lantus were achieved without corresponding weight gain.  

The second study involved 89 type 1 patients who initiated Lantus as their basal insulin instead of NPH, and 60 type 2 patients who either added Lantus to their current oral treatments or were switched to Lantus as the basal insulin within their combination regimen. After nine months of follow up, the type 1 patients had achieved a 1.1 percent reduction in HbA1c levels, and the type 2 patients experienced a .50 percent HbA1c reduction. In addition, patients in the study demonstrated a significant overall weight loss. 

In the final study, 72 type 2 diabetes patients were enrolled in a nine-month study of Lantus which evaluated both its impact on metabolic control and weight loss. Thirty-two insulin naïve patients previously treated with oral antidiabetic medications were switched to once-daily Lantus with either Amaryl (glimepiride; an oral diabetes medication), or Amaryl and metformin. The remaining 40 patients, who were previously treated with insulin, were switched to once-daily Lantus plus mealtime regular insulin. Both groups received specialized treatment education programs. At 9 months of follow up, the Lantus plus Amaryl, or Amaryl and metformin, group achieved a 1.6 percent reduction in HbA1c levels while body weight was reduced versus baseline. Of the 40 patients previously treated with insulin, 13 who previously received mixed insulin showed a 1.7 percent HbA1c reduction; 15 who previously received oral agents plus NPH insulin experienced a 1.5 percent reduction in HbA1c; and the 12 patients previously on intensified conventional therapy showed an expected slight trend toward increased HbA1c levels. Among these 40 patients, no statistically significant change in body weight from baseline was detected.