drugset / Trial / NCT00309244
Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up
RandomizedParallel-groupOpen-labelPrevention
Summary
The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.
Timeline
- Start
- 2006-02
- Primary completion
- 2008-08
- Completion
- 2008-09
Publications
- Peyrot M, Rubin RR. Patient-reported outcomes in adults with type 2 diabetes using mealtime inhaled technosphere insulin and basal insulin versus premixed insulin. Diabetes Technol Ther. 2011 Dec;13(12):1201-6. doi: 10.1089/dia.2011.0037. Epub 2011 Oct 14.
- Rosenstock J, Lorber DL, Gnudi L, Howard CP, Bilheimer DW, Chang PC, Petrucci RE, Boss AH, Richardson PC. Prandial inhaled insulin plus basal insulin glargine versus twice daily biaspart insulin for type 2 diabetes: a multicentre randomised trial. Lancet. 2010 Jun 26;375(9733):2244-53. doi: 10.1016/S0140-6736(10)60632-0.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | 15 iu | Other |
| Subject | Insulin | Protein / enzyme biologic | 30 iu | Other |
| Comparator | insulin aspart | Protein / enzyme biologic | — | Subcutaneous |