Multicentre clinical study of the efficacy and safety of INHaled INSulin aerosol in the treatment of 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). CONDITION: Type 2 diabetes ; Nutritional, Metabolic, Endocrine ; Diabetes PRIMARY OUTCOME: The change in HbA1c from baseline until week 12. SECONDARY OUTCOME: 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) 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