Insulin Glulisine in Diabetes Mellitus, Type 2
Summary
Primary objective: The primary study objective is to demonstrate superior efficacy of an intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of change in glycated hemoglobin A1c (HbA1c), from baseline to endpoint. Secondary objectives: Secondary study objectives are to compare the intensified insulin regimen with insulin glulisine and insulin glargine to a two-injection conventional insulin regimen in terms of blood glucose (BG) values (fasting, pre-/postprandial (ppBG), nocturnal, mean daily, fasting plasma glucose), daily BG profiles, BG and HbA1c response rates (predefined), hypoglycemic events, adverse events, change of late diabetes complications, weight, body-mass-index, course of total daily insulin dose and adjustment, blood lipid profile, microalbuminuria, standard lab and quality of life/treatment satisfaction.
Timeline
- Start
- 2004-11
- Primary completion
- 2007-11
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Insulin | Protein / enzyme biologic | — | — |
| Subject | Insulin glulisine | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | insulin aspart | Protein / enzyme biologic | — | — |
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | neutral protamine Hagedorn | Unknown | — | — |