中华医学杂志（英文版）2008，Vol.121Issue(13)：1159-1164,6.
Multicenter clinical study on the efficacy and safety of inhalable insulin aerosol in the treatment of type 2 diabetes
Multicenter clinical study on the efficacy and safety of inhalable insulin aerosol in the treatment of type 2 diabetes
LIAO Zhi-hong 1WENG Jian-ping 2CHEN Ying-li 3LI Fang-ping 4YAN Xiang 5LU Hai 3YAN Li 4ZHOU Zhi-guang 5ZHU Da-long 2JI Li-nong1
作者信息
- 1. Department of Endocrinology,First Affiliated Hospital of Sun Yat-sen University,Guangzhou,Guangdong 510080,China
- 2. Department of Endocrinology,People's Hospital of Peking University,Beijing 100044,China
- 3. Department of Endocrinology,Sun Yat-sen Memorial Hospital of Sun Yat-sen University,Guangzhou,Guangdong 510120,China
- 4. Department of Endocrinology,Second Xiangya Hospital of Central-South University,Changsha,Hunan 410011,China
- 5. Department of Endocrinology,Affiliated Drum Tower Hospital of Nanjing University of Medical School,Nanjing,Jiangsu 210008,China
- 折叠
摘要
Abstract
Background A new inhalable insulin aerosoI(Inh-Ins)was developed in China.The aim of this multicenter clinical study was to evaluate the efficacy and safety of this new Inh-Ins as a treatment of type 2 diabetes.Regular porcine insulin(RI)was used as a control.Methods This study is a prospective,randomized,open-label,parallel-group multicenter clinical trial in which 253 qualified patients with type 2 diabetes received the insulin Glargine daily at bedtime plus either a pre-meal Inh-Ins or a pre-meal subcutaneous RI for 12 weeks.HbA1c,fasting plasma glucose(FPG),the 1-hour-postprandial blood glucose(1hPBG)and the 2-hour-postprandial blood glucose(2hPBG)were measured.Events were monitored for adverse effects.Results After 12 weeks,the HbA1c decreased significantly from baseline in both treatment groups,with no significant difference between the two regimens.In the Inh-Ins group,FPG,both 1hPBG and 2hPBG significantly declined from baseline after the 8th-and 12th-weeks of treatment.The reduced values of FPG or 1hPBG between the two groups showed a more significant hypoglycemic effect with the Inh-Ins than the RI.After 12 weeks,the pulmonary carbon monoxide diffusing capacity(DLco)was significantly lower in Inh-Ins group than in the RI.The main side effects of Inh-Ins were coughing,excessive sputum,and hypoglycemia.Conclusions Inh-Ins was effective in decreasing HbA1c like the RI.It was better in lowering the FPG and the 1hPBG than the RI.Its main side effects were coughing,excessive sputum,and hypoglycemia.Also,Inh-Ins slightly impaired DLco.关键词
insulin/regular,aerosols/type 2 diabetes mellitus/multicenter studyKey words
insulin/regular,aerosols/type 2 diabetes mellitus/multicenter study分类
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LIAO Zhi-hong,WENG Jian-ping,CHEN Ying-li,LI Fang-ping,YAN Xiang,LU Hai,YAN Li,ZHOU Zhi-guang,ZHU Da-long,JI Li-nong..Multicenter clinical study on the efficacy and safety of inhalable insulin aerosol in the treatment of type 2 diabetes[J].中华医学杂志（英文版）,2008,121(13):1159-1164,6.
