drugset / Trial / NCT02194595
Preserving Beta-cell Function in Type 2 Diabetes With Exenatide and Insulin (PREVAIL)
Phase 3
Completed
105 enrolled
Mount Sinai Hospital, Canada
Canadian Institutes of Health Research (CIHR) · collabUniversity of Toronto · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Type 2 diabetes mellitus is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a randomized controlled trial to determine whether combining basal insulin with a new medication called exenatide is a therapeutic strategy that can preserve beta-cell function early in the course of type 2 diabetes.
Timeline
- Start
- 2014-09
- Primary completion
- 2021-12
- Completion
- 2022-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Exenatide | Peptide | 10 ug | Subcutaneous |
| Comparator | Insulin Lispro | Protein / enzyme biologic | — | — |
| Subject | insulin glargine | Protein / enzyme biologic | — | Subcutaneous |