drugset / Trial / NCT00670228
Effect of Lantus and Apidra in Patients With Acute ST Elevation Myocardial Infarction
RandomizedParallel-groupOpen-labelTreatment
Summary
Primary objective: To demonstrate that in hyperglycemic subjects with anterior STEMI (ST Elevation Myocardial Infarction) undergoing Percutaneous Coronary Intervention (PCI), tight glycemic control using insulin glulisine and insulin glargine, i.e. Intensive Insulin Therapy (IIT), results in reducing infarct size at day 60 versus (vs) Standard Glycemic Care (SGC). Secondary objectives: To demonstrate that tight glycemic control using insulin glulisine and insulin glargine reduces markers of inflammation and improves Left Ventricular (LV) function and Cardio-Vascular (CV) outcomes from baseline values, in hyperglycemic subjects with STEMI undergoing Percutaneous Coronary Intervention (PCI).
Timeline
- Start
- 2008-04
- Primary completion
- 2009-11
- Completion
- 2009-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin glulisine | Protein / enzyme biologic | 2 iu | Intravenous |
| Comparator | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |
Indications
No indication recorded.