drugset / Trial / NCT00942318

Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes

NCT00942318

Phase 4 Completed 52 enrolled University Hospital, Toulouse
RandomizedParallel-groupOpen-labelTreatment

Summary

A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous insulin infusion (CSII), using an external pump, could be a solution to improve diabetes control. The aim of this study is to compare, over a one-year period, the efficacy of CSII (with aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x 2/d and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen for at least 6 months, who didn't reach adequate target for glycemic at baseline (HbA1c\>7 -10%).

Timeline

Start
2009-03
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject insulin aspart Protein / enzyme biologic Subcutaneous
Subject insulin glargine Protein / enzyme biologic Other
Background Metformin Small molecule Oral