drugset / Trial / NCT03350984
Insulin Schemes for Type 2 Diabetes Control
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of the study is to determine differences in glycemic control between a basal-bolus scheme insulin and NPH scheme insulin in a population of hospitalized patients with type 2 diabetes in a Noncritical Care Facility in Mexico. Patients with a recent diagnosis of type 2 and patients on treatment with oral hypoglycaemic agents and insulin or only insulin were included. The primary outcome of the study is to determine difference in efficacy and security between a basal-bolus scheme insulin and NPH scheme insulin in patients with type 2 diabetes hospitalized in non-critical areas in a hospital in Mexico
Timeline
- Start
- 2017-11-02
- Primary completion
- 2018-07-01
- Completion
- 2018-07-01
Publications
- Background Umpierrez GE, Smiley D, Jacobs S, Peng L, Temponi A, Mulligan P, Umpierrez D, Newton C, Olson D, Rizzo M. Randomized study of basal-bolus insulin therapy in the inpatient management of patients with type 2 diabetes undergoing general surgery (RABBIT 2 surgery). Diabetes Care. 2011 Feb;34(2):256-61. doi: 10.2337/dc10-1407. Epub 2011 Jan 12.
- Background Umpierrez GE, Smiley D, Hermayer K, Khan A, Olson DE, Newton C, Jacobs S, Rizzo M, Peng L, Reyes D, Pinzon I, Fereira ME, Hunt V, Gore A, Toyoshima MT, Fonseca VA. Randomized study comparing a Basal-bolus with a basal plus correction insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes: basal plus trial. Diabetes Care. 2013 Aug;36(8):2169-74. doi: 10.2337/dc12-1988. Epub 2013 Feb 22.
- Background Christensen MB, Gotfredsen A, Norgaard K. Efficacy of basal-bolus insulin regimens in the inpatient management of non-critically ill patients with type 2 diabetes: A systematic review and meta-analysis. Diabetes Metab Res Rev. 2017 Jul;33(5). doi: 10.1002/dmrr.2885. Epub 2017 Feb 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | — | — |
| Comparator | Insulin Lispro | Protein / enzyme biologic | — | — |
| Comparator | insulin glargine | Protein / enzyme biologic | — | — |