Haemodialyzed, Type 2 DiabetesPhase 4NCT02176681
A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM
A Phase 4 study testing Vildagliptin (Galvus) and Insulin in people with Haemodialyzed, Type 2 Diabetes, run by University Hospital, Strasbourg, France at 13 sites in France.
Trial summary
Diabetes is a major concern for dialysis units, as it is now the most common cause of end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2 diabetes) and especially in East part of France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodialyzed, Type 2 Diabetes
- What is being tested?
- Vildagliptin (Galvus) and Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 13 sitesFrance
- Study dates
- Jun 2014to Oct 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated by haemodialysis for more than 3 months with 1g/L glucose in dialysate fluid
- Patients treated by stable doses of insulin (any regimen) for Type 2 diabetes without any oral antidiabetic agent
- Age > 18 years
- TGO, TPO and lipase < 3x ULN
- effective means of contraception
- Non-inclusion Criteria:
Show all 19Show fewer
- Blood transfusion in the 2 previous months
- Life expectancy less than 1 year
- Chronic inflammatory disease
- Steroid treatment > 5mg/day
- Cancer (evolutive or requiring chemotherapy or radiotherapy) with the exception of breast intraductal carcinoma operated
- Patient waiting for programmed surgery
- History of cardiovascular disease (stroke, coronary heart disease, hospitalization for heart failure) in the 4 previous months
- Patients suffering from stage 3 and 4 cardiac insufficiency
- Non-compliant patients
- History of pancreatitis
- History of angioedema
- Hypersensitivity to the active substance or to any of the excipients of Galvus®
- Pregnancy or breastfeeding
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CH d'Amiens
Amiens, 80054
CH de Besançon
Besançon, 25030
AURAL Colmar
Colmar, 68000
Hospices civils de Colmar
Colmar, 68024
CH de Dijon
Dijon, 21079
AURAL Mulhouse
Mulhouse, 68070
CH de Mulhouse
Mulhouse, 68070
CH de Nancy
Nancy, 54000
AURAL Clinique Sainte Anne
Strasbourg, 67000
Clinique Sainte Anne
Strasbourg, 67000
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
AURAL Strasbourg
Strasbourg, 67200
CH de Valenciennes
Valenciennes, 59300
About this study
Diabetes is a major concern for dialysis units, as it is now the most common cause of end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2 diabetes) and especially in East part of France.
Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients has an important impact in reducing risk of progression nephropathy. Data are scarce on how diabetes should best be treated in dialysis patients. The evidence for improving glycaemic control in patients on dialysis having an impact on mortality or morbidity is sparse. Indeed, many factors make improving glycaemic control in patients on dialysis very challenging, including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties, dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.
Read more
Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment. Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues have become available, but until recently, renal failure has precluded their use. Newer gliptins, however, are now licensed for use in 'severe renal failure', although they have yet to be trialed in dialysis patients.
The investigators study, using continuous glucose monitoring as a new tool for monitoring of therapy should provide information on vildagliptin in add on therapy to insulin in this population.
- Conditions
- Haemodialyzed, Type 2 Diabetes
- Being tested
- Vildagliptin (Galvus), Insulin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vildagliptin (Galvus)Drug
Use Vildagliptin (50 mg/day) added to insulin during 3 months
InsulinDrug
Insulin
| Study group | Role | What they receive |
|---|---|---|
| Insulin alone | Active comparator | Use the usual frequency and dose Receives: Drug: Insulin |
| Insulin and Vildagliptin | Experimental | vildagliptin 50 mg/day during 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM
Measured: up to day 3
Secondary outcomes (3)
CGM parameters at baseline and month 3
glucose area under the curve (AUC) for glucose value higher than 7.7 mmol/l
- number of glucose values under 3.3 mmol/l
- hypoglycaemic events at baseline, month 3
- number of minor hypoglycaemic events per month
- number of major hypoglycaemic events at month 3
- number of nocturnal hypoglycaemic events per month
- variability glycemic index: MAGE, CV
Measured: Other CGM parameters at baseline and month 3
Number of hypoglycaemic events
hypoglycaemic events at baseline, month 3
- number of minor hypoglycaemic events per month
- number of major hypoglycaemic events at month 3
- number of nocturnal hypoglycaemic events per month
Measured: Hypoglycaemic events at baseline, month 3
Mean HbA1C and Glycated albumin
Measured: HbA1C and Glycated albuminat baseline and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemodialyzed, Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- François CHANTREL, MD, Principal investigator, AURAL - MulhouseAlexandre KLEIN, MD, Principal investigator, Hospices Civils de ColmarOlivier IMHOFF, MD, Principal investigator, AURAL Clinique Saint-Anne de StrasbourgAlexandre KLEIN, MD, Principal investigator, AURAL - ColmarDominique FLEURY, MD, Principal investigator, CH de ValenciennesBruno VERGES, MD-PhD, Principal investigator, Centre Hospitalier Universitaire DijonPhilippe ZAOUI, MD-PhD, Principal investigator, University Hospital, GrenoblePhilippe ZAOUI, MD-PH, Principal investigator, AGDUC - Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176681
- Sponsor's protocol ID
- 5706
- Other IDs
- 2013-004737-33
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2014
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Munch M, Meyer L, Hannedouche T, Kunz K, Alenabi F, Winiszewski P, Baltzinger P, Smagala A, Klein A, Dorey F, Fleury D, Verier-Mine O, Guerci B, Cridlig J, Borot S, Ducloux D, Meyer N, Hadjadj S, Chantrel F, Kessler L. Effect of adding vildagliptin to insulin in haemodialysed patients with type 2 diabetes: The VILDDIAL study, a randomized, multicentre, prospective study. Diabetes Obes Metab. 2020 Jun;22(6):978-987. doi: 10.1111/dom.13988. Epub 2020 Feb 25.
PubMed 32048396
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Open-label Study of 12 Week Duration to Evaluate the Effect of VILDagliptin Added to Insulin on Glycaemic Control in haemoDIALyzed Patients With Type 2 Diabetes: Probe Analysis of CGM
- ClinicalTrials.gov ID
- NCT02176681
- Acronym / sponsor ID
- 5706
- Conditions
- Haemodialyzed, Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Jun 2014 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 27 Jun 2014 (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.
Diabetes is a major concern for dialysis units, as it is now the most common cause of end-stage renal disease in France. In 2010 at initiation of dialysis treatment, more than one patient out of two had at least one cardiovascular disease and 40 % diabetes (94 % Type 2 diabetes) and especially in East part of France.
Diabetic patients on dialysis have a high burden of morbidity and mortality, particularly from cardiovascular disease. Tight glycaemic and blood pressure control in diabetic patients has an important impact in reducing risk of progression nephropathy. Data are scarce on how diabetes should best be treated in dialysis patients. The evidence for improving glycaemic control in patients on dialysis having an impact on mortality or morbidity is sparse. Indeed, many factors make improving glycaemic control in patients on dialysis very challenging, including therapeutic difficulties with hypoglycaemic agents, monitoring difficulties, dialysis strategies that exacerbate hyperglycaemia or hypoglycaemia.
Standard oral drugs therapy for hyperglycaemia (eg, metformin, sulfonylureas, ) are contraindicated in patients on dialysis. Thus insulin has been the mainstay of treatment. Newer therapies for hyperglycaemia, such as gliptins and glucagon-like peptide-1 analogues have become available, but until recently, renal failure has precluded their use. Newer gliptins, however, are now licensed for use in 'severe renal failure', although they have yet to be trialed in dialysis patients.
The investigators study, using continuous glucose monitoring as a new tool for monitoring of therapy should provide information on vildagliptin in add on therapy to insulin in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin alone | Active comparator | Drug: InsulinUse the usual frequency and dose |
| Insulin and Vildagliptin | Experimental | –vildagliptin 50 mg/day during 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients treated by haemodialysis for more than 3 months with 1g/L glucose in dialysate fluid
- Patients treated by stable doses of insulin (any regimen) for Type 2 diabetes without any oral antidiabetic agent
- Age > 18 years
- TGO, TPO and lipase < 3x ULN
- effective means of contraception
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vildagliptin (Galvus)Use Vildagliptin (50 mg/day) added to insulin during 3 months | Drug | – |
| InsulinInsulin | Drug | Insulin alone |
Primary outcome
Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM
Time frame: up to day 3
3 secondary outcomes
CGM parameters at baseline and month 3
Time frame: Other CGM parameters at baseline and month 3
Number of hypoglycaemic events
Time frame: Hypoglycaemic events at baseline, month 3
Mean HbA1C and Glycated albumin
Time frame: HbA1C and Glycated albuminat baseline and month 3
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 16 Mar 2026.
- Results publication: PubMed 32048396Munch M, Meyer L, Hannedouche T, Kunz K, Alenabi F, Winiszewski P, Baltzinger P, Smagala A, Klein A, Dorey F, Fleury D, Verier-Mine O, Guerci B, Cridlig J, Borot S, Ducloux D, Meyer N, Hadjadj S, Chantrel F, Kessler L. Effect of adding vildagliptin to insulin in haemodialysed patients with type 2 diabetes: The VILDDIAL study, a randomized, multicentre, prospective study. Diabetes Obes Metab. 2020 Jun;22(6):978-987. doi: 10.1111/dom.13988. Epub 2020 Feb 25.
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.
François CHANTREL, MD principal investigator
AURAL - Mulhouse
Alexandre KLEIN, MD principal investigator
Hospices Civils de Colmar
Olivier IMHOFF, MD principal investigator
AURAL Clinique Saint-Anne de Strasbourg
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vildagliptin (Galvus) and Insulin in people with Haemodialyzed, Type 2 Diabetes, run by University Hospital, Strasbourg, France at 13 sites 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 19 inclusion and 0 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM (time frame: up to day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02176681, which also lists 1 linked publication.
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 16 Mar 2026.