Efficacy and Safety of Insulin Glargine in Concurrent Use with Oral Hypoglycemic Agents for the Treatment of Type 2 Diabetic Patients
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Accession number;03A0402377
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| Title;Efficacy and Safety of Insulin Glargine in Concurrent Use with Oral Hypoglycemic Agents for the 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)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.5;PAGE.445-464(2003)
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| Figure&Table&Reference;FIG.8, TBL.5, REF.15 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;The basic principles of the treatment of Type 2 diabetes consist of compensating for impaired secretion of insulin and counteracting insulin resistance; however, many patients are difficult to treat exclusively with oral antidiabetic drugs. Currently available drugs used to control blood glucose levels are neutral protamine Hagedorn human insulins (NPH) or extended insulin drugs, which have several problems. Insulin glargine (glargine) has been developed to improve such problems and to mimic physiological basal secretion patterns. This was an active controlled parallel open study carried out at 64 institutes in Japan to investigate the efficacy and safety of 28-week administration of glargine for the treatment of Type 2 diabetic patients who had been given oral antidiabetic drugs. NPH was used as the control. The total number of registered patients was 400, with 335 assigned to one or other of the preparations (167 for glargine and 168 for NPH), and 65 not assigned. HbA1c, a primary efficacy measure, decreased time-dependently in both groups, showing a statistically significant decrease. There were no statistically significant differences in the degree of change between the groups. HbA1c at 28 weeks was 7.98.+-.0.09% for the glargine group and 8.09.+-.0.09% for the NPH group, showing similar levels. Although sufficient control in blood glucose levels is not yet achieved, a decrease of more than 1% was confirmed with basal insulin supplement, suggesting the effect of suppression of progression of complications. This study has revealed that glargine given before breakfast has the effect of sufficiently compensating for basal insulin in the same way as with NPH in concomitant therapy with oral antidiabetic drugs for the treatment of Type 2 diabetic patients.... (author abst.) |
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