drugset / Trial / NCT01452113
Effect of Autonomic Neuropathy on the Efficacy of a DPP-IV Inhibitor (Galvus) Therapy
Phase 2
Completed
21 enrolled
University Hospital, Toulouse
Faculty of Medicine, Toulouse · collabInstitute of Molecular Medicine of Rangueil (I2MR) · collabNovartis Pharmaceuticals · collab
Non-randomizedParallel-groupOpen-labelBasic science
Summary
The purpose of this study is to compare the effect of a single administration of a DPP-IV inhibitor (vildagliptin: Galvus ®) versus no treatment over two populations of diabetic patients: without diabetic autonomic neuropathy (NA, i.e. the control group) and with diabetic autonomic neuropathy (i.e. the neuropathy group). The investigators hypothesize that the therapeutic efficacy of DPP-IV inhibitors is partly mediated by the autonomic nervous system. This hypothesis will be validated if a lower glycemic response to DPP-IV inhibitor treatment is observed for the neuropathy group compared to control.
Timeline
- Start
- 2010-10
- Primary completion
- 2013-01
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vildagliptin | Other / unclassified | 50 mg | Oral |