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Study Shows Lantus(R) Helped People Living with Type 2 Diabetes Reach the ADA's Recommended Target for Blood Sugar Control
Date:6/7/2008

tients dropped out of the trial due to hypoglycaemia.

"When glycemic targets are not achieved with diet, exercise and oral medications given at maximum tolerated dose, patients with type 2 diabetes have reached a critical moment in the lifecycle of their condition," said Andre Grimaldi, MD, Professor Diabetes Department Head, Pitie-Salpetriere Hospital, Paris, France. "The results observed in TULIP demonstrate the value of following the ADA/EASD treatment recommendations by initiating basal insulin therapy in a timely manner."

About the TULIP Study

TULIP is a 9-month, 12-visit, open-label, multinational, multicenter, randomized study to evaluate starting Lantus(R) or intensifying lifestyle management in type 2 diabetes patients aged 40-75 years, body mass index (BMI) 24-35 kg/m2 and A1C 7-8%, treated with maximum doses of metformin and sulfonylurea for greater than or equal to 2 years. Lantus(R) was injected once-daily and titrated to capillary fasting blood glucose 70-100 mg/dL. In the lifestyle management arm, dietary and physical activity counseling recommended stable weight for people with BMI<27 kg/m2 or weight loss of 3 kg for patients with BMI greater than or equal to 27 kg/m2. 215 patients were randomized to Lantus(R) (n=106) or lifestyle management (n=109).

The primary objective was the percentage of patients achieving A1C <7% at endpoint. Secondary endpoints included changes in A1C and fasting plasma glucose (FPG), and hypoglycemia incidence.

211 (52.6% male) patients were randomized and treated; mean ( +/-standard deviation) age 60.7 +/- 7.9 years, weight 84.5 +/- 13.1 kg, BMI 29.9 +/- 3.5 kg/m2 and A1C 7.6 +/- 0.4%. More patients reached A1c <7% (66 vs 38%; p<0.0001) or <6.5% (34 vs 11%; p<0.0001) with Lantus(R) versus lifestyle management. In contrast to the Lantus(R)-treated group, the lifestyle management-treated group showed a decrease in weight (+0.9 +/- 2.9 vs -2.5 +/- 3.2 kg; p<0.0001) as well as the expected low
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SOURCE sanofi-aventis
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