drugset / Trial / NCT00393705

Lispro Mid Mixture (MM) Intensive Mixture Therapy With Progressive Dose-Titration of Lispro Low Mixture (LM) or Biphasic Insulin Aspart 30/70 (S019)

NCT00393705

Phase 4 Completed 302 enrolled Eli Lilly and Company
RandomizedParallel-groupOpen-labelTreatment

Summary

Investigation into patients with type 2 diabetes mellitus not achieving adequate glycemic control while treated with combination of premixed insulin analogue formulations twice daily and metformin will be randomly assigned to follow one of two insulin treatment strategies used in combination with metformin administration. The aim of the trial is to try to achieve optimal metabolic control and explore full therapeutic potential of the strategies, patients in both arms will follow progressive insulin dose titration algorithms for 16 weeks.

Timeline

Start
2006-10
Primary completion
2009-03
Completion
2009-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Biphasic Aspart 30/70 Unknown Subcutaneous
Subject Insulin Lispro Protein / enzyme biologic Subcutaneous