drugset / Trial / NCT00110370
Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes
RandomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.
Timeline
- Start
- 2004-04
- Primary completion
- —
- Completion
- 2006-04
Outcome
Missed primary endpoint
paper Noninferiority of PPT to BBT was not demonstrated based on the prespecified noninferiority margin of 0.3%. PMID 17934150 ↗
Publications
- Shi LX, Li PF, Hou JN. Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens. Diabetes Ther. 2017 Aug;8(4):915-928. doi: 10.1007/s13300-017-0286-z. Epub 2017 Jun 30.
- Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008 Jan;31(1):20-5. doi: 10.2337/dc07-1122. Epub 2007 Oct 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin Lispro | Protein / enzyme biologic | — | — |
| Subject | Lispro Mixture Therapy | Unknown | — | — |
| Subject | insulin glargine | Protein / enzyme biologic | — | — |