Multicentre clinical study of the efficacy and safety of INHaled INSulin aerosol in the treatment of type 2 diabetes
| ISRCTN | ISRCTN81772352 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81772352 |
| Secondary identifying numbers | C20030218 |
- Submission date
- 20/10/2007
- Registration date
- 16/11/2007
- Last edited
- 08/08/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jianping Weng
Scientific
Scientific
Dept of Endocrinology
First Affiliated Hospital of Sun Yatsen University
Guangzhou
510080
China
Study information
| Study design | A randomised, open-labelled, parallel controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | INH-INS |
| Study objectives | Inhaled insulin plus a single injection of insulin glargine can provide glycaemic control comparable to a conventional subcutaneous insulin regimen in type 2 diabetes patients who previously managed with at least two daily subcutaneous injections of insulin. |
| Ethics approval(s) | Ethics approval received from the First Affiliated Hospital of Sun Yatsen University on the 1st July 2005. |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | This is a randomised, open-labeled, parallel control study, consists of a screening visit, a 2-week baseline lead-in phase, and a 12-week treatment phase. All subjects received insulin glargine at bedtime as basal insulin supply in the two phases. During the baseline period, all subjects received subcutaneous regular human insulin (RI) injections at 30 minutes before each meal (3 times per day). Then, during the treatment phase, the patients were randomised to receive an inhaled insulin regimen or continue receiving RI subcutaneous therapy as the run-in phase. Inhaled Insulin aerosol capsular (Inh-Ins) was given at 10 minutes before each meal (3 times per day), each capsule contained 40 IU insulin. All patients followed the instruction of diet, exercise and self monitoring of blood glucose (SMBG). The dose of insulins was adjusted at the discretion of the investigator, based on SMBG results, to achieve target of 4.4 - 7.8 mmol/L for fasting or pre-meal, less than 10 mmol/L for postprandial, 5.6 - 8.9 mmol/L before bedtime. Hypoglycaemia should be avoided as much as possible. The insulin dosage is varied from patient to patient. At the end of the study, in the treatment group, the mean dose of Inh-Ins was about 240 IU per day, and in control group, the mean dose of RI was about 27 IU per day. The total duration of both treatment lasted for 12 weeks, and the follow-up for all treatment arms was 16 weeks (4 more weeks after the treatment). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Insulin aerosol, insulin glargine |
| Primary outcome measure | The change in HbA1c from baseline until week 12. |
| Secondary outcome measures | 1. The change of FPG from baseline until week 8 and week 12 2. 1-hour and 2-hour postprandial blood glucose (1hPBG and 2hPBG) response, using a standardised breakfast (330 Kcal of Glucerna-SR) |
| Overall study start date | 22/08/2005 |
| Completion date | 05/07/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 252 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/08/2005 |
| Date of final enrolment | 05/07/2006 |
Locations
Countries of recruitment
- China
Study participating centre
Dept of Endocrinology
Guangzhou
510080
China
510080
China
Sponsor information
Chuangxinhui Biotech Venture Capital Co., Ltd (China)
Industry
Industry
Kai Yuan Building, Room 2210-2212
Bei Huan Da Dao, No 7001
Shenzhen
518000
China
Funders
Funder type
Industry
Chuangxinhui Biotech Venture Capital Co. Ltd (China)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
