Status:
COMPLETED
Effect of Autonomic Neuropathy on the Efficacy of a DPP-IV Inhibitor (Galvus) Therapy
Lead Sponsor:
University Hospital, Toulouse
Collaborating Sponsors:
Institute of Molecular Medicine of Rangueil (I2MR)
Faculty of Medicine, Toulouse
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 diab...
Detailed Description
Recently published work has demonstrated in animals that the control of pancreatic hormone secretion is due, at least in part, to the action of GLP-1 on the via the autonomic nervous system. Therefore...
Eligibility Criteria
Inclusion
- type 1 diabetes mellitus
- multiple daily insulin injections therapy or continuous insulin infusion (insulin pomp) therapy
- recent (\<1 year) written diagnosis of autonomic neuropathy available
- ewing score \> 2 for patients to be included in the "neuropathy" group
- ewing score \<= 0.5 for patients to be included in the '"control" group
- HbA1C \<= 10% at the screening visit and stable (+/- 1%)between the autonomous neuropathy diagnosis and the inclusion visit
Exclusion
- severe chronic renal insufficiency defined by an estimated GFR\<30 ml/min calculated by MDRD formula)
- proliferative retinopathy needing panphotocoagulation
- hepatic enzymes (ALAT, ASAT) greater than 3 times the upper limit
- congestive heart failure of NYHA functional class III-IV
- clinical signs of gastroparesis
- ongoing gastric emptying therapy
- history of bariatric surgery
- galvus therapy contra indications: known allergy or hypersensitivity of princeps or excipients, galactose intolerance, lapp lactase deficiency, glucose - galactose malabsorption
- ongoing systemic corticoids therapy
- metformin therapy during the day before each study visit
- haemoglobin alteration
- pregnancy or pregnancy willing
- lactation
- ongoing clinical study participation
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01452113
Start Date
October 1 2010
End Date
March 1 2013
Last Update
March 12 2014
Active Locations (1)
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1
UH Toulouse
Toulouse, France, 31059