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

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ClinicalTrials.gov Identifier: NCT01452113
Recruitment Status : Completed
First Posted : October 14, 2011
Last Update Posted : March 12, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Vildagliptin Phase 2

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, rhe investigators hypothesized that altered autonomic nervous system could explain, at least in part, the altered therapeutic efficacy of DPP-IV inhibitors observed in some patients. Our aim is to validate this concept in humans.

The objective of this physiopathological, monocentric, comparative, open, parallel study is to compare the effect of a single administration of a DPP-IV (vildagliptin: Galvus ®) over two populations of type 1 diabetic patients: a control group of 12 patients without diabetic autonomic neuropathy (NA) and a group of 12 patients with NA.

This proof of concept study will enrol type 1 diabetic patients to avoid confounding factors related to endogen insulin secretion and frequent polymedication of type 2 diabetic patients. The response will be evaluated for each patient by the relative difference between pre-and post-glucagon concentrations following a test meal, measured in the absence and presence of treatment with DPP4 inhibitor. Expected results: the DPP-4 inhibitor should lead to a reduction of about 20 to 30% of the glucagon level in patients without NA and a smaller or no decrease in patients with NA.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effect of a DPP-IV Inhibitor Treatment on the Secretion of Glucagon in Patients Presenting With Type 1 Diabetes Mellitus With or Without Autonomic Neuropathy
Study Start Date : October 2010
Primary Completion Date : January 2013
Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
patients with autonomic neuropathy
Drug: Vildagliptin
one 50 mg tablet per os
Other Name: GALVUS
patients without autonomic neuropathy (ewing score <= 0.5)
Drug: Vildagliptin
one 50 mg tablet per os
Other Name: GALVUS

Outcome Measures

Primary Outcome Measures :
  1. plasma glucagon concentration [ Time Frame: 120 min post stantardized meal ]

Secondary Outcome Measures :
  1. GLP-1 [ Time Frame: T-30, 0, 15, 30, 60, 90, 120, 180 min post standardized meal ]
  2. GIP [ Time Frame: T-30,0, 15, 30, 60, 90, 120, 180 min post standardized meal ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452113

UH Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Institute of Molecular Medicine of Rangueil (I2MR)
Faculty of Medicine, Toulouse
Novartis Pharmaceuticals
Study Director: Remy Burcelin, PHD Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Hélène Hanaire, MD PHD UH Toulouse
More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01452113     History of Changes
Other Study ID Numbers: 1004003
First Posted: October 14, 2011    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014

Keywords provided by University Hospital, Toulouse:
Diabetes Mellitus
DPP-IV protein
Glucagon-Like Peptide 1
autonomic neuropathy

Additional relevant MeSH terms:
Diabetes Mellitus
Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents