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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004737-33 | EudraCT Number |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin alone | Active Comparator | Use the usual frequency and dose |
|
| Insulin and Vildagliptin | Experimental | vildagliptin 50 mg/day during 3 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vildagliptin (Galvus) | Drug | Use Vildagliptin (50 mg/day) added to insulin during 3 months | ||
| Insulin |
| Measure | Description | Time Frame |
|---|---|---|
| Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM | up to day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| CGM parameters at baseline and month 3 | glucose area under the curve (AUC) for glucose value higher than 7.7 mmol/l
| Other CGM parameters at baseline and month 3 |
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Inclusion Criteria:
Non-inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| François CHANTREL, MD | AURAL - Mulhouse | Principal Investigator |
| Alexandre KLEIN, MD | Hospices Civils de Colmar | Principal Investigator |
| Olivier IMHOFF, MD | AURAL Clinique Saint-Anne de Strasbourg | Principal Investigator |
| Alexandre KLEIN, MD | AURAL - Colmar | Principal Investigator |
| Dominique FLEURY, MD | CH de Valenciennes | Principal Investigator |
| Bruno VERGES, MD-PhD | Centre Hospitalier Universitaire Dijon | Principal Investigator |
| Philippe ZAOUI, MD-PhD | University Hospital, Grenoble | Principal Investigator |
| Philippe ZAOUI, MD-PH | AGDUC - Grenoble | Principal Investigator |
| Gabriel CHOUKROUN, MD PhD | Centre Hospitalier Universitaire, Amiens | Principal Investigator |
| Joëlle CRIDLIG, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'Amiens | Amiens | 80054 | France | |||
| CH de Besançon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32048396 | Result | 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. |
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| Drug |
Insulin |
|
| Number of hypoglycaemic events | hypoglycaemic events at baseline, month 3
| Hypoglycaemic events at baseline, month 3 |
| Mean HbA1C and Glycated albumin | HbA1C and Glycated albuminat baseline and month 3 |
| Central Hospital, Nancy, France |
| Principal Investigator |
| Sophie BOROT, MD | CHU de Besançon | Principal Investigator |
| François CHANTREL, MD | CH de Mulhouse | Principal Investigator |
| Olivier IMHOFF, MD | Clinique Sainte Anne de Strasbourg | Principal Investigator |
| Kristian KUNTZ, MD | AURAL de Strasbourg | Principal Investigator |
| Besançon |
| 25030 |
| France |
| AURAL Colmar | Colmar | 68000 | France |
| Hospices civils de Colmar | Colmar | 68024 | France |
| CH de Dijon | Dijon | 21079 | France |
| AURAL Mulhouse | Mulhouse | 68070 | France |
| CH de Mulhouse | Mulhouse | 68070 | France |
| CH de Nancy | Nancy | 54000 | France |
| AURAL Clinique Sainte Anne | Strasbourg | 67000 | France |
| Clinique Sainte Anne | Strasbourg | 67000 | France |
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
| AURAL Strasbourg | Strasbourg | 67200 | France |
| CH de Valenciennes | Valenciennes | 59300 | France |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077597 | Vildagliptin |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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