Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01219959 | Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients | PHASE3 | COMPLETED | 71 | — | — | Oct 1, 2010 | Jul 1, 2011 | Jul 24, 2025 | 16 | Colombia |
HbA1c is a specific glycohemoglobin, and adduct of glucose attached to the beta-chain terminal valine residue. Measured using a Tina-quant immunological assay suitable for samples from end stage renal disease (ESRD) patients and with icodextrin metabolites or equivalent. Statistical analysis includes estimates of Least Squares (LS) comparing differences between treatment groups by visit and p-value using analysis of covariance (ANOVA) testing that the differences=0.
| Arm | Type | Description |
|---|---|---|
| Non-glucose Sparing | ACTIVE_COMPARATOR | Dianeal only |
| Glucose Sparing | EXPERIMENTAL | Dianeal, Extraneal, Nutrineal |
| Name | Type | Description |
|---|---|---|
| Dianeal | DRUG | Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose |
| Dianeal, Extraneal, Nutrineal | DRUG | Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin |
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% bu...