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Accession number;02A0353231
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| Title;Clinical Study on Insulin Lispro Mixture-25 and Mixture-50 Administered Twice Daily in Insulin-requiring Patients with Type 1 and Type 2 Diabetes Mellitus. |
| Author;
IWAMOTO YASUHIKO
(Tokyo Women's Medical College, Diabetic Center)
KAWAMORI RYUZO
(Juntendodai I Taishanaibumpitsugaku)
KADOWAKI TAKASHI
(Todai Daigakuin'igakukenkyuka Tonyobyotaishanaika)
AKANUMA YASUO
(Asahi Life Found., Inst. for Diabetes Care and Res.)
BEATTIE S D
(Eli Lilly And Co.)
MALONE J K
(Eli Lilly And Co.)
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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.18;NO.3;PAGE.395-409(2002)
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| Figure&Table&Reference;FIG.1, TBL.9, REF.14 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;To evaluate the efficacy and safety of insulin lispro Mixture-25 and Mixture-50, we conducted an open-label clinical study on insulin lispro mixtures for 12 weeks of treatment. Mixture-25 was administered just before breakfast and dinner to the patients who had been treated with human insulin 30/70. Mixture-50 was administered in the same manner to the patients who had been treated with human insulin 50/50. The mean changes of efficacy and safety parameters from baseline to endpoint(12 week) were tested. Two hundred twenty-six patients with type 1 or type 2 diabetes were treated in this study. Two hundred fourteen patients completed the 12 weeks of treatment. The morning 2-hour postprandial blood glucose was significantly reduced by -17.8mg/dL after 12 weeks of treatment compared to human insulin mixtures with the similar insulin dose. The hemoglobin A1c was significantly reduced by -0.13% as well. One hundred and sixteen patients, 51.3%, reported at least one treatment emergent adverse events. The most frequent reported adverse events were rhinitis(16.4%),headache(3.1%), and constipation(2.7%). The incidence of hypoglycemia was 25.2% at baseline and 29.6% after 12 weeks. There was no statistically significant change from baseline to endpoint. The cross reactive antibody against human insulin and insulin lispro was tested. There was no statistically significant change. Overall, we concluded that insulin lispro mixture Mix25 and Mix50 has the same safety profile as the human insulin mixture 30/70 and 50/50, and a better efficacy profile in terms of postprandial blood glucose and hemoglobin A1c for 12 weeks of treatment. Insulin lispro Mix25 and Mix50 were demonstrated to be valuable insulin lispro formula for patients treated with insulin therapy. (author abst.) |
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