Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
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.
Timeline
- Start
- 2010-10
- Primary completion
- 2011-07
- Completion
- 2011-07
Outcome
Met primary endpoint
registry analysis (superiority test); Non-Glucose Sparing Prescriptions vs Glucose Sparing Prescriptions; p <0.001; Mean Difference (Final Values) 0.6 (95% CI 0.2 to 0.9); ANOVA NCT01219959 ↗
registry analysis (superiority test); Non-Glucose Sparing Prescriptions vs Glucose Sparing Prescriptions; p = 0.006; Mean Difference (Final Values) 0.5 (95% CI 0.1 to 0.8); ANOVA NCT01219959 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dianeal | Unknown | 1.5 % | — |
| Comparator | Dianeal | Unknown | 2.5 % | — |
| Comparator | Dianeal | Unknown | 4.25 % | — |
| Subject | Icodextrin | Other / unclassified | 7.5 % | — |
| Subject | Nutrineal | Unknown | 1.1 % | — |