Multicentre clinical study of the efficacy and safety of INHaled INSulin aerosol in the treatment of type 2 diabetes

Completed

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine; Diabetes

• Registration Number: ISRCTN81772352
• Lead Sponsor: Chuangxinhui Biotech Venture Capital Co., Ltd (China)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 252

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

1. Asthma
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in HbA1c from baseline until week 12.

Secondary Outcome Measures

Name	Time	Method
1. The change of FPG from baseline until week 8 and week 12<br>2. 1-hour and 2-hour postprandial blood glucose (1hPBG and 2hPBG) response, using a standardised breakfast (330 Kcal of Glucerna-SR)