Comparison of Efficacy between Insulin Glargine and NPH Human Insulin in Type 1 Diabetes Patients undergoing Intensive Insulin Treatment-Phase II/ III Clinical Studies in Japan-

Accession number;03A0402376
Title;Comparison of Efficacy between Insulin Glargine and NPH Human Insulin in Type 1 Diabetes Patients undergoing Intensive Insulin Treatment-Phase II/ III Clinical Studies in Japan-
Author;KAWAMORI RYUZO(Juntendo Univ., School of Medicine, JPN)   IWAMOTO YASUHIKO(Diabetes Center, Tokyo Women's Medical Univ., JPN)   KADOWAKI TAKASHI(Univ. Hospital, Fac. Medicine, Univ. Tokyo, JPN)   IWASAKI MANABU(Seikei Univ., Fac. Engineering, JPN)   
Journal Title;Journal of Clinical Therapeutics & Medicines
Journal Code:Y0906A
ISSN:0910-8211
VOL.19;NO.5;PAGE.423-444(2003)
Figure&Table&Reference;FIG.13, TBL.7, REF.12
Pub. Country;Japan
Language;Japanese
Abstract;At present, the standard intensive insulin treatment of Type 1 diabetes is a combination of a rapidly acting insulin drug before eating and a neutral protamine Hagedorn human insulin (NPH) before going to bed. However, attempts to control the blood insulin level by NPH or extended insulin preparations aiming at compensating for basal secretions is known to have several problems, such as generating peaks in blood insulin levels, insufficient duration of action, and variability in absorption by subcutaneous tissue. Insulin glargine (glargine) is a long-acting insulin analogue dissolved in an aqueous fluid that has been developed to improve the above problems of NPH and extended insulin preparations and to achieve a basal secretion pattern of insulin that is as physiological as possible. This study was a multicenter collaborative active controlled open study where efficacy and safety were compared between NPH and glargine that had been given for 28 weeks aiming at compensating for basal insulin secretion in an intensive insulin treatment for Japanese Type 1 diabetic patients. The total number of registered patients was 370, with 293 assigned to either of the preparations (145 for glargine and 148 for NPH), and 77 not assigned. In the glargine group, HbA1c decreased to 7.71 % immediately after starting administration, 7.52 % at 4 weeks, and remained low up to 28 weeks. In the NPH group, there were no changes up to 28 weeks. A Wilcoxon test revealed that the degree of change in HbA1c showed a statistically significant difference (p=0.0356). It is concluded that in intensive insulin treatment in Type 1 diabetic patients, glargine given before going to bed shows good efficacy as an insulin preparation for supplementing basal insulin secretion via decreasing the incidence of night hypoglycemia and suppressing the elevation of fasting blood glucose before breakfast. (author abst.)