drugset / Trial / NCT00979628
Basal Bolus Versus Basal Insulin in Type 2 Diabetes Mellitus (T2DM)
Phase 4
Completed
375 enrolled
Guillermo Umpierrez, MD
Medical University of South Carolina · collabSanofi · collabTexas A&M University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is a prospective randomized study comparing safety and effectiveness of a basal-bolus regimen with glargine once daily and glulisine before meals, a basal plus regimen with glargine once daily and supplemental doses of glulisine, and sliding scale regular insulin (SSI) on correction of insulin regimen for the hospital management of medical and surgical patients with type 2 diabetes.
Timeline
- Start
- 2010-01
- Primary completion
- 2012-03
- Completion
- 2012-06
Publications
- Results 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.
- Umpierrez GE, Reyes D, Smiley D, Hermayer K, Khan A, Olson DE, Pasquel F, Jacobs S, Newton C, Peng L, Fonseca V. Hospital discharge algorithm based on admission HbA1c for the management of patients with type 2 diabetes. Diabetes Care. 2014 Nov;37(11):2934-9. doi: 10.2337/dc14-0479. Epub 2014 Aug 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin | Protein / enzyme biologic | — | Subcutaneous |
| Subject | Insulin glulisine | Protein / enzyme biologic | — | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |