drugset / Trial / NCT01855243
Comparison on Efficacy and Safety of Three Inpatient Insulin Therapy in Type2 DM
RandomizedParallel-groupOpen-labelTreatment
Summary
Purpose: To compare efficacy and safety of traditional sliding scale insulin (SSI) versus modified 70/30 insulin versus modified basal plus supplemental scale /bolus insulin regimens for glycemic control in hospitalized diabetic patients with diabetes. Methods: In a prospective trial, patients with diabetes will be randomized to receive either traditional hospital SSI , or twice daily 70/30 insulin plus supplemental lunchtime insulin for BG ≥ 150 mg/dL or once every night glargine plus three times prandial glulisine for BG ≥ 150 mg/dL . 70/30 insulin and glargine will be started respectively at 0.4 and 0.2 U/kg/day for BG ≤ 200 mg/dL or 0.5 and 0.3 U/kg/day for BG above 200 mg/dL.
Timeline
- Start
- 2010-03
- Primary completion
- 2014-02
- Completion
- 2014-06
Publications
- Background Umpierrez GE, Smiley D, Zisman A, Prieto LM, Palacio A, Ceron M, Puig A, Mejia R. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes (RABBIT 2 trial). Diabetes Care. 2007 Sep;30(9):2181-6. doi: 10.2337/dc07-0295. Epub 2007 May 18.
- Background Umpierrez GE, Hor T, Smiley D, Temponi A, Umpierrez D, Ceron M, Munoz C, Newton C, Peng L, Baldwin D. Comparison of inpatient insulin regimens with detemir plus aspart versus neutral protamine hagedorn plus regular in medical patients with type 2 diabetes. J Clin Endocrinol Metab. 2009 Feb;94(2):564-9. doi: 10.1210/jc.2008-1441. Epub 2008 Nov 18.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 70/30 insulin | Unknown | 0.4 iu/kg | — |
| Comparator | 70/30 insulin | Unknown | 0.5 iu/kg | — |
| Comparator | Insulin | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | Insulin glulisine | Protein / enzyme biologic | — | — |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.2 iu/kg | — |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.3 iu/kg | — |