drugset / Trial / NCT00494013
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes (IOOY)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to examine the effectiveness and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin therapy in adults with type 2 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.
Timeline
- Start
- 2007-08
- Primary completion
- 2008-09
- Completion
- 2008-09
Outcome
Met primary endpoint
registry analysis (non-inferiority or equivalence test); Insulin Lispro Protamine Suspension vs Detemir; p = 0.026; Mean Difference (Net) -0.21 (95% CI -0.39 to -0.03); ANCOVA NCT00494013 ↗
paper At end-point, ILPS was non-inferior to detemir in HbA(1c) change from baseline. PMID 20546262 ↗
Publications
- Qu Y, Jacober SJ, Zhang Q, Wolka LL, DeVries JH. Rate of hypoglycemia in insulin-treated patients with type 2 diabetes can be predicted from glycemic variability data. Diabetes Technol Ther. 2012 Nov;14(11):1008-12. doi: 10.1089/dia.2012.0099.
- Fogelfeld L, Dharmalingam M, Robling K, Jones C, Swanson D, Jacober S. A randomized, treat-to-target trial comparing insulin lispro protamine suspension and insulin detemir in insulin-naive patients with Type 2 diabetes. Diabet Med. 2010 Feb;27(2):181-8. doi: 10.1111/j.1464-5491.2009.02899.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin detemir | Protein / enzyme biologic | — | Subcutaneous |