At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multi-center, Prospective, Randomized Trial to Demonstrate Improved Metabolic Control of Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in the Treatment of Diabetic CAPD Patients
In Brief
A Phase 3 clinical trial evaluating Dianeal and Dianeal, Extraneal, Nutrineal for End Stage Renal Disease (ESRD) and 2 related conditions. Completed, enrolled 71 participants across 16 sites.
Detailed Summary
Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life.
Study Details
Timeline
Interventions
Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose
Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin