drugset / Trial / NCT01175824
Comparison of the Efficacy and Safety of Two Insulin Intensification Strategies
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is a comparison of twice-daily insulin lispro low mixture versus once-daily basal insulin glargine and once-daily prandial insulin lispro, in participants with Type 2 Diabetes.
Timeline
- Start
- 2011-04
- Primary completion
- 2012-11
- Completion
- 2012-11
Publications
- Rojas A, Sposetti G, Gross JL, Barbieri DE, Duan R, Linetzky B, De Lana JM, Stempa O, Rodriguez A. Insulin lispro low mixture twice daily vs basal insulin glargine once daily and prandial insulin lispro once daily as insulin intensification strategies in patients with type 2 diabetes: Latin American subpopulation analysis of a randomized trial. Diabetol Metab Syndr. 2016 Sep 17;8:69. doi: 10.1186/s13098-016-0163-3. eCollection 2016.
- Gross JL, Rojas A, Shah S, Tinahones FJ, Cleall S, Rodriguez A. Efficacy and safety of a premixed versus a basal-plus insulin regimen as intensification for type 2 diabetes by timing of the main meal. Curr Med Res Opin. 2016 Jun;32(6):1109-16. doi: 10.1185/03007995.2016.1161609. Epub 2016 Apr 7.
- Tinahones FJ, Gross JL, Onaca A, Cleall S, Rodriguez A. Insulin lispro low mixture twice daily versus basal insulin glargine once daily and prandial insulin lispro once daily in patients with type 2 diabetes requiring insulin intensification: a randomized phase IV trial. Diabetes Obes Metab. 2014 Oct;16(10):963-70. doi: 10.1111/dom.12303. Epub 2014 May 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |