NCT01452113

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 diabetes-mellitus

Timeline
Completed

Started Oct 2010

Typical duration for phase_2 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 14, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

2.3 years

First QC Date

February 9, 2011

Last Update Submit

March 11, 2014

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusDPP-IV proteinGlucagon-Like Peptide 1autonomic neuropathy

Outcome Measures

Primary Outcomes (1)

  • plasma glucagon concentration

    120 min post stantardized meal

Secondary Outcomes (2)

  • GLP-1

    T-30, 0, 15, 30, 60, 90, 120, 180 min post standardized meal

  • GIP

    T-30,0, 15, 30, 60, 90, 120, 180 min post standardized meal

Study Arms (2)

neuropathy

OTHER

patients with autonomic neuropathy

Drug: Vildagliptin

control

OTHER

patients without autonomic neuropathy (ewing score \<= 0.5)

Drug: Vildagliptin

Interventions

VildagliptinDRUG

one 50 mg tablet per os

Also known as: GALVUS
controlneuropathy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Vildagliptin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Remy Burcelin, PHD

    Institut National de la Santé Et de la Recherche Médicale, France

    STUDY DIRECTOR

  • Hélène Hanaire, MD PHD

    UH Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2011

First Posted

October 14, 2011

Study Start

October 1, 2010

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

FR(1)