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Clinical Trial Details

Trial ID: L4007
Source ID: NCT02176681
Associated Drug: Vildagliptin (Galvus)
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
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Haemodialyzed, Type 2 Diabetes
Interventions: DRUG: Vildagliptin (Galvus)|DRUG: Insulin
Outcome Measures: Primary: Mean glucose value of CGM [M] to be averaged from day 2 and day 3 of CGM, up to day 3 | Secondary: 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, 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, Hypoglycaemic events at baseline, month 3|Mean HbA1C and Glycated albumin, HbA1C and Glycated albuminat baseline and month 3
Sponsor/Collaborators: Sponsor: University Hospital, Strasbourg, France | Collaborators: Novartis
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 70
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-06
Completion Date: 2017-10
Results First Posted:
Last Update Posted: 2017-11-17
Locations: CH d'Amiens, Amiens, 80054, France|CH de Besançon, Besancon, 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
URL: https://clinicaltrials.gov/show/NCT02176681