Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients (EDEN)

Vantive Health LLC

Status and phase: Completed; Phase 3

Conditions: Diabetes; CAPD; End Stage Renal Disease (ESRD)

Treatments: Drug: Dianeal; Drug: Dianeal, Extraneal, Nutrineal

Study type: Interventional

Funder types: Industry

Identifiers

NCT01219959

51067

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female patients 18 years of age or older
2. Diagnosis of ESRD [Glomerular Filtration Rate (GFR) ≤ 15 mL/min]
3. CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
4. Diabetes Mellitus (Type 1 and 2)
5. HbA1c > 6.0% but ≤ 12.0%
6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
7. Total Kt/V ≥ 1.7

Exclusion criteria

1. Blood Urea Nitrogen (BUN) > 95 mg/dL
2. Exposure to Extraneal within 60 days of Screening
3. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77mm Hg) at Screening
4. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
5. Cardiovascular event within the last 30 days
6. Ongoing clinically significant congestive heart failure [New York Heart Association (NYHA) class III or IV]
7. Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance
8. Receiving rosiglitazone maleate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Non-glucose Sparing

Active Comparator group

Description:

Dianeal only

Treatment:

Drug: Dianeal

Glucose Sparing

Experimental group

Description:

Dianeal, Extraneal, Nutrineal

Treatment:

Drug: Dianeal, Extraneal, Nutrineal