Diabetes MellitusPhase 2DPPNACNCT01452113
Effect of Autonomic Neuropathy on the Efficacy of a DPP-IV Inhibitor (Galvus) Therapy
A Phase 2 study testing Vildagliptin in people with Diabetes Mellitus, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Vildagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Vildagliptin
- Keywords
- Diabetes Mellitus, DPP-IV protein, Glucagon-Like Peptide 1, autonomic neuropathy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
Also called GALVUS
one 50 mg tablet per os
| Study group | Role | What they receive |
|---|---|---|
| neuropathy | Other | patients with autonomic neuropathy Receives: Drug: Vildagliptin |
| control | Other | patients without autonomic neuropathy (ewing score <= 0.5) Receives: Drug: Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma glucagon concentration
Measured: 120 min post stantardized meal
Secondary outcomes (2)
GLP-1
Measured: T-30, 0, 15, 30, 60, 90, 120, 180 min post standardized meal
GIP
Measured: T-30,0, 15, 30, 60, 90, 120, 180 min post standardized meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startOct 2010
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Molecular Medicine of Rangueil (I2MR), Faculty of Medicine, Toulouse, Novartis Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Remy Burcelin, PHD, Study director, Institut National de la Santé Et de la Recherche Médicale, FranceHélène Hanaire, MD PHD, Principal investigator, UH Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452113
- Sponsor's protocol ID
- 1004003
- Acronym
- DPPNAC
- Status last verified
- Mar 2014
- First submitted
- 9 Feb 2011
- Last updated
- 12 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01452113
- Acronym / sponsor ID
- DPPNAC / 1004003
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, DPP-IV protein, Glucagon-Like Peptide 1, autonomic neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Institute of Molecular Medicine of Rangueil (I2MR), Faculty of Medicine, Toulouse, Novartis Pharmaceuticals
- Study start
- Oct 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| neuropathy | Other | Drug: Vildagliptinpatients with autonomic neuropathy |
| control | Other | Drug: Vildagliptinpatients without autonomic neuropathy (ewing score <= 0.5) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VildagliptinAlso: GALVUSone 50 mg tablet per os | Drug | control, neuropathy |
Primary outcome
plasma glucagon concentration
Time frame: 120 min post stantardized meal
2 secondary outcomes
GLP-1
Time frame: T-30, 0, 15, 30, 60, 90, 120, 180 min post standardized meal
GIP
Time frame: T-30,0, 15, 30, 60, 90, 120, 180 min post standardized meal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remy Burcelin, PHD study director
Institut National de la Santé Et de la Recherche Médicale, France
Hélène Hanaire, MD PHD principal investigator
UH Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vildagliptin in people with Diabetes Mellitus, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma glucagon concentration (time frame: 120 min post stantardized meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.