Effect of Autonomic Neuropathy on the Efficacy of a DPP-IV Inhibitor (Galvus) Therapy

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Collaborators: Faculty of Medicine, Toulouse; Institute of Molecular Medicine of Rangueil (I2MR); Novartis Pharmaceuticals
• Treatments: Glucagon; Vildagliptin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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