Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
C20030218
Study information
Scientific title
Acronym
INH-INS
Study hypothesis
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
Ethics approval received from the First Affiliated Hospital of Sun Yatsen University on the 1st July 2005.
Study design
A randomised, open-labelled, parallel controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
22/08/2005
Overall trial end date
05/07/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
252
Participant 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
Recruitment start date
22/08/2005
Recruitment end date
05/07/2006
Locations
Countries of recruitment
China
Trial participating centre
Dept of Endocrinology
Guangzhou
510080
China
Funders
Funder type
Industry
Funder name
Chuangxinhui Biotech Venture Capital Co. Ltd (China)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list