Efficacy and safety of HOE 901 versus NPH insulin in patients with type 1 diabetes

OBJECTIVE - HOE 901 (Hoechst Marion Roussel, Frankfurt, Germany) is a biosy nthetic insulin with a prolonged action. The aim of this study was to compa re the effect of the long-acting insulin analog HOE 901 with NPH insulin re garding glycemic control in patients with type 1 diabetes. RESEARCH DESIGN END METHODS - A total of 133 type 1 diabetic patients were enrolled in this multinational parallel group trial. Subjects were randomiz ed either to two different formulations of HOE 901 (the formulations differ ed only in zinc content) or to NPH insulin. The study was only partially bl inded because patients can distinguish HOE 901 (a clear solution) from NPH (a cloudy suspension). In addition to premeal injections of regular insulin , patients received HOE 901 at bedtime or NPH once daily at bedtime or twic e daily in the morning and at bedtime. RESULTS - Fasting plasma glucose levels were significantly lower with HOE 9 01 (-1.88 mmo/1, P = 0.0005) as were fasting self-monitored blood glucose l evels (-0.80 mmol/1, P = 0.0020). HbA(1C) levels also showed a significant reduction with HOE 901 (-0.14%) versus NPH (P = 0.030). The overall frequen cy of hypoglycemia did not differ, but the frequency of nocturnal hypoglyce mia was significantly (P = 0.0037) lower with HOE 901 (36 vs. 55%). However , this effect on nocturnal hypoglycemia was significant only versus NPH onc e daily, not NPH twice daily The pattern of adverse events and injection si te reactions with HOE 901 was similar to that with NPH. CONCLUSIONS - This study indicates that HOE 901 achieves better control of fasting glucose and HbA(1C) levels over 4 weeks, and HOE 901 has a possible safety benefit in terms of nocturnal hypoglycemia.