ISRCTN81772352
Completed
Not Applicable
Multicentre clinical study of the efficacy and safety of INHaled INSulin aerosol in the treatment of type 2 diabetes
Chuangxinhui Biotech Venture Capital Co., Ltd (China)0 sites252 target enrollmentNovember 16, 2007
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 diabetes
- Sponsor
- Chuangxinhui Biotech Venture Capital Co., Ltd (China)
- Enrollment
- 252
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women (n \= 253\) diagnosed with type 2 diabetes were screened out at five centres in China. Inclusion criteria were:
- •1\. Aged 18 to 65 years
- •2\. Stable subcutaneous insulin schedule involving two to three injections daily for at least 2 months before study entry and not receiving any oral antidiabetic agents for at least 1 month
- •3\. Screening and pre\-randomisation fasting plasma glucose (FPG) values not more than 13mmol/L, body mass index (BMI) 18 \- 28 kg/m^2
- •3\. Written informed consent
Exclusion Criteria
- •2\. Chronic obstructive pulmonary disease or other significant respiratory disease
- •3\. Smoking during the last 6 months
- •4\. Abnormal screening chest X\-ray
- •5\. Abnormal pulmonary function at screening (carbon monoxide diffusing capacity \[DLCO] less than 75%, total lung capacity \[TLC] less than 80 or greater than 120%, and forced expiratory volume in one second \[FEV1] less than 70% of predicted)
- •6\. Major organ system disease
- •7\. Clinically significant abnormalities on laboratory screening
- •8\. Concomitant therapy with systemic glucocorticoids
- •9\. Any inhaled insulin clinical trial previously
- •10\. A daily insulin requirement of greater than 1\.0 U/Kg
Outcomes
Primary Outcomes
Not specified
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