Diabetes Clinical Trial
Official title:
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
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.
n/a
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