Sanofi-aventis (SNY) Reports Results of Long-Term, 5-Yr Study of Lantus(R) vs. NPH Insulin

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July 6, 2009 8:18 AM EDT

Sanofi-aventis (NYSE: SNY) announced today that the results of the long-term, 5-year study of Lantus(R) (insulin glargine [rDNA] injection) versus NPH insulin on progression of retinopathy in patients with type 2 diabetes, published on-line in Diabetologia (DOI 10.1007/s00125-009-1415-7) showed similar effects on retinopathy and overall safety in the two treatment groups. This is the longest controlled study ever reported using insulin glargine.

Diabetic retinopathy is a major cause of blindness in patients with diabetes. It is a progressive disease that results from cellular proliferation within the eye. The stimulation of IGF1 receptors is involved in this process. In the study of patients with retinopathy, the progression of diabetic retinopathy was similar in the two treatment groups over the long-term course of treatment.

This indicates that Lantus does not have mitogenic effects different from the human NPH insulin within the eye.

The 5-year open-label study was specifically designed to further characterize the retinal safety profile of Lantus(R) versus NPH in 1024 patients (Lantus(R) once daily: 515 patients; NPH twice daily: 509 patients). Retinopathy progression was assessed using serial fundus photography.

Progression was evaluated using the Early Treatment Diabetic Retinopathy Study (ETDRS) scale; the scores at study end were similar in both treatment groups (Lantus(R): 14.2%, NPH: 15.7%; 95% CI: -7.02, 3.06). As per protocol, the study aimed to achieve similar levels of glycemic control in both groups, in order to avoid introducing bias on the primary retinopathy end-point that could be related to differences in blood glucose control. Both groups had comparable HbA1c at study end (mean HbA1c improved from a baseline of 8.4% and 8.3% to 7.8% and 7.6% for all patients in the insuline glargine and NPH insulin groups respectively). NPH insulin was associated with a significantly greater incidence of severe hypoglycemia than was insulin glargine (11.1% vs 7.6% respectively, p=0.0439) and mean yearly rates of symptomatic hypoglycemia (7.08+/-16.49 vs 5.13+/-12.79, p=0.0017).

There was no observable trend for a difference in the incidence of serious adverse events including cancer, as well as adverse events leading to study withdrawal. The most common adverse events in the study were: upper respiratory tract infection (glargine 149 [29%], NPH 169 [33.6%]), peripheral edema (glargine 103 [20%], NPH 114 [22.7%]), and arthralgia (glargine 73 [14.2%], NPH 81 [16.1%]).