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Accession number;03A0624378
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| Title;4 Weeks Trial with Biphasic Insulin Aspart 30 in Type 2 Diabetes (NIDDM): Phase II Clinical Trial |
| Author;
SHICHIRI MOTOAKI
(Kumamoto Univ., Med. Sch.)
KAKU KOHEI
(Kawasaki Medical School, 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.8;PAGE.881-890(2003)
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| Figure&Table&Reference;FIG.5, TBL.7, REF.15 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;Biphasic insulin aspart 30 (BIAsp3O) is a premixed insulin analogue that contains soluble (rapid-acting) insulin aspart (IAsp) and protamine crystallized (intermediate-acting) IAsp in a ratio of 30%:70%. The purpose of this trial was to evaluate the glycaemic control and safety of BIAsp30 administered twice daily in subjects with Type 2 diabetes (non-insulin dependent diabetes mellitus) previously treated with biphasic human insulin 30 (BHI30) twice daily. BIAsp30 was administered for four weeks immediately before morning and evening meals with the same dosage prescribed for BHI30 prior to this trial. A total of 29 subjects were exposed to BIAsp 30 and 28 of them were included in the efficacy analysis. There were no statistically significant changes in glycaemic control parameters (fasting blood glucose, 2-hour postprandial blood glucose, fructosamine and glycoalbumin) after 4 weeks of treatment with BIAsp 30 from baseline. Seventeen adverse events related to the trial drug were observed in 9 subjects, of which 8 events were hypoglycaemic episodes. There were no statistically significant changes in laboratory tests, blood pressure and body weight. The overall safety rating was assessed individually by the investigator throughout the trial. The proportion of "no safety problem "and"almost no safety problems"was 96.6% (28 of 29 subjects) in the evaluation of overall safety rating. In conclusion, the results of this trial suggested that BIAsp3O can be introduced to patients being treated with biphasic human insulin at the same dosage. (author abst.) |
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