Type 2 diabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
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 bed
Sponsors
Chuangxinhui Biotech Venture Capital Co., Ltd (China)
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in HbA1c from baseline until week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
China
Outcome results
None listed