Efficacy and Safety of Insulin Glargine in the Long-term Treatment of Type 2 Diabetic Patients
|
Accession number;03A0402378
|
| Title;Efficacy and Safety of Insulin Glargine in the Long-term Treatment of Type 2 Diabetic Patients |
| 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.465-481(2003)
|
| Figure&Table&Reference;FIG.4, TBL.9, REF.12 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Currently available insulin preparations for the treatment of diabetes include neutral protamine Hagedorn human insulin (NPH) and extended insulin zinc suspension; however, NPH generates peaks in blood insulin levels and acting duration is short, and extended insulin is unstable with respect to its absorption from subcutaneous tissue and causes daily variance. Therefore, there are demands for the development of a long-acting insulin preparation that mimics physiological basal insulin patterns and provides stable hypoglycemic action. Insulin glargine is an insulin analogue. Its isoelectric point is modified from about pH 5.4, that of conventional human insulin, to about pH 6.7 by substituting glycine for aspartic acid at the 21st position in the human insulin A chain and adding 2 arginine residues to B31 and B32 at the C terminal of the B chain. Due to these substitutions, the agent is immediately rendered insoluble at physiological pH due to isoelectric point deposition, and is instead absorbed via the capillary vessels as it slowly dissolves. Thanks to this mechanism,' the agent generates no definitive peaks in its blood levels, unlike NPH, and thus maintains low blood glucose levels. To confirm the efficacy and safety of long-term administration of glargine in diabetic patients, in this study, glargine was further given to 137 subjects (74 Type 1 diabetic patients and 63 Type 2 diabetic patients) for another 28 weeks, 56 weeks in total, following the 28-week comparative study using NPH as control. The 137 subjects had been assigned to the glargine group, judged to be able to start the additional study. They had given their consent to participating in the study.... (author abst.) |
|
|
|
Related Articles;
|
|
