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5-Year Study Published in Diabetologia Demonstrated Long-Term Safety of Lantus(R) Compared to NPH
Date:7/6/2009

ep progression in the Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy patient-level severity scale after treatment with either insulin. Masked, centralized grading of seven-field stereoscopic fundus photographs was used.

Main characteristics of the population were the following and well balanced between groups: : mean age 55, 54% males, mean baseline HbA1c 8.4 vs 8.3% (glargine vs NPH) diabetes duration 11 years, and about 70% of the population was already treated with insulin prior to study entry.

Similarly sustained glycaemic control was observed in both the glargine and NPH treatment groups. Despite a slightly greater severity of diabetic retinopathy for the glargine-treated group at baseline, greater than or equal to 3-step progression in ETDRS score from baseline to end-of-study was similar between treatment groups (14.2% [53/374] of glargine-treated patients vs 15.7% [57/363] of NPH-treated patients). Other measures of retinopathy - the development of proliferative diabetic retinopathy and progression to clinically significant macular oedema - occurred to a similar degree in both treatment groups. Rates of symptomatic and clinically important hypoglycaemia were significantly lower in the glargine group: 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). Body weight gain tended to be greater with NPH insulin compared with insulin glargine treatment, with a baseline to endpoint increase in mean body weight of 3.7 kg for insulin glargine and 4.8 kg for NPH insulin (ITT population; p=0.0505). No other safety issues for either insulin emerged during the 5-year study.

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