Phase 3
N=251
Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients
End Stage Renal Disease (ESRD) · Diabetes · CAPD
Bottom Line
View on ClinicalTrials.gov: NCT01219959 ↗Enrolled (actual)
251
Serious AEs
39.4%
Results posted
Jun 2019
Primary outcome: Primary: Change From the Baseline Value in HbA1c at Month 3 and 6 — 0.2; -0.6; 0; -0.6 Percent Change — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dianeal (Drug); Dianeal, Extraneal, Nutrineal (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vantive Health LLC
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From the Baseline Value in HbA1c at Month 3 and 6 |
0.2; -0.6; 0; -0.6 | <0.001 sig |
| SECONDARY Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 |
3.5; -3.3; 2.9; -3.8; 1.3; 5 | 0.312 |
| SECONDARY Number of Severe Hypoglycemic Event Requiring Medical Intervention |
1; 3 | — |
| SECONDARY Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 |
0.1; -0.5; 0; -0.4; 0.1; -0.2 | 0.010 sig |
| SECONDARY Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 |
2.3; 3.3; 6.7; 6.8; -2.1; -9.3 | 0.485 |
| SECONDARY Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 |
70.3; 69.4; 146.3; 96.6; 340.8; 70.5 | 0.655 |
| SECONDARY Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6 |
-1.8; 13; 3; 0.4 | 0.721 |
| SECONDARY Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 |
1; 2; 19; 24; 76; 57 | 0.624 |
| SECONDARY Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 |
-0.1; -0.6; 0.5; -0.8; 0.1; 0.2 | 0.338 |
| SECONDARY Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 |
-0.8; 12.8; 1; 12.9; 0; 0.2 | 0.127 |
| SECONDARY Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6 |
0.4; -1.9; -1.0; -2.9 | 0.019 sig |
| SECONDARY Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6 |
-0.2; -0.2; 0.2; -0.7 | 0.884 |
| SECONDARY Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6 |
-0.1; -0.1; 0.1; -0.3 | 0.961 |
| SECONDARY Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6 |
0; 0.4 | 0.871 |
| SECONDARY Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 |
-5.6; -4.9; -0.1; 4.5; -76.8; -199.1 | 0.608 |
| SECONDARY Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6 |
-0.01; -0.04; -0.04; -0.03 | 0.412 |
| SECONDARY Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6 |
-2.33; -2.58; -1.60; 0.92 | 0.525 |
| SECONDARY Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 |
2.34; 2.39; 2.48; -0.49; 0.16; 2.66 | 0.526 |
| SECONDARY Change From Baseline of MRI Body Composition at Month 6 |
-49; -64.8; -12; -3.3 | 0.495 |
| SECONDARY Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6 |
2.1; 0.7; 3.3; -0.2 | 0.626 |
| SECONDARY Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6 |
0.6; 3.3; 1.1; 3.5 | 0.832 |
| SECONDARY Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6 |
-0.3; 0.9 | 0.955 |
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.
Eligibility Criteria
Inclusion Criteria
- Male or Female patients 18 years of age or older
- Diagnosis of ESRD [Glomerular Filtration Rate (GFR) ≤ 15 mL/min]
- CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
- Diabetes Mellitus (Type 1 and 2)
- HbA1c > 6.0% but ≤ 12.0%
- Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
- Total Kt/V ≥ 1.7
Exclusion Criteria
- Blood Urea Nitrogen (BUN) > 95 mg/dL
- Exposure to Extraneal within 60 days of Screening
- Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77mm Hg) at Screening
- Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
- Cardiovascular event within the last 30 days
- Ongoing clinically significant congestive heart failure [New York Heart Association (NYHA) class III or IV]
- Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance
- Receiving rosiglitazone maleate
Data sourced from ClinicalTrials.gov (NCT01219959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.