drugset / Trial / NCT01146678
Relative Bioavailability and Activity of Different Formulations of Insulin Glargine and Lixisenatide in Patients With Diabetes Mellitus Type 1
RandomizedCrossoverOpen-labelTreatment
Summary
Primary Objective: * to assess the relative bioavailability of a single dose of insulin glargine (Lantus) and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug Secondary Objectives: * to compare the activity of a single dose of insulin glargine and lixisenatide given subcutaneously as on-site mix versus separate and simultaneous injections of each drug * to assess the safety and tolerability of insulin glargine and lixisenatide given subcutaneously as on-site mix
Timeline
- Start
- 2010-06
- Primary completion
- 2010-09
- Completion
- 2011-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lixisenatide | Peptide | 20 ug | Subcutaneous |
| Subject | insulin glargine | Protein / enzyme biologic | 0.6 iu/kg | Subcutaneous |