drugset / Trial / NCT01195454
Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®
RandomizedCrossoverDouble-blindTreatment
Summary
Primary Objective: \- To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus® Secondary Objectives: * To assess the exposure ratios of a new insulin glargine formulation versus Lantus® * To compare the duration of action of a new insulin glargine formulation versus Lantus® * To explore the dose response and dose exposure relationship of a new insulin glargine formulation * To assess the safety and tolerability of a new insulin glargine formulation
Timeline
- Start
- 2010-08
- Primary completion
- 2010-11
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |