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IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients (Impendia)

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ClinicalTrials.gov Identifier: NCT00567398
Recruitment Status : Completed
First Posted : December 5, 2007
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions ESRD
Diabetes
Interventions Drug: Dianeal
Drug: Physioneal
Drug: Extraneal
Drug: Nutrineal
Enrollment 43
Recruitment Details The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.
Pre-assignment Details  
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Period Title: Overall Study
Started 127 124
Completed 120 101
Not Completed 7 23
Reason Not Completed
Adverse Event             6             14
Physician Decision             0             4
Withdrawal by Subject             0             2
Renal Transplantation             0             3
Other             1             0
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions Total
Hide Arm/Group Description Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study. Total of all reporting groups
Overall Number of Baseline Participants 127 124 251
Hide Baseline Analysis Population Description
The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants 124 participants 251 participants
58  (12.8) 57.3  (12) 57.65  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 124 participants 251 participants
Female
59
  46.5%
64
  51.6%
123
  49.0%
Male
68
  53.5%
60
  48.4%
128
  51.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Baseline Number Analyzed 127 participants 124 participants 251 participants
Asian
41
  32.3%
42
  33.9%
83
  33.1%
Black
1
   0.8%
0
   0.0%
1
   0.4%
Caucasian
41
  32.3%
41
  33.1%
82
  32.7%
Hispanic
32
  25.2%
31
  25.0%
63
  25.1%
Other
12
   9.4%
10
   8.1%
22
   8.8%
1.Primary Outcome
Title Change From the Baseline Value in HbA1c at Month 3 and 6
Hide Description 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Efficacy Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489, NCT00567398, NCT01219959.
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 125 119
Mean (Standard Deviation)
Unit of Measure: Percent Change
Month 3 0.2  (1.1) -0.6  (1.3)
Month 6 0  (1.2) -0.6  (1.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.2 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.1 to 0.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6
Hide Description This data used diabetic prescription drug information from insulin and oral glycemic control concomitant medications reported. Glycemic control medications classes allowed were limited to insulin, sulfonylureas, and thiazolidinediones. Subjects were provided with a paper diary on which they recorded doses of all glycemic control medications taken for 1 day prior to the Screening visit and for 8 days prior to the study visits at Month 3 and Month 6. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis used data from prescription information of concomitant medications reported. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 126 124
Mean (Standard Deviation)
Unit of Measure: Percent Change
Insulin: Month 3 3.5  (21.2) -3.3  (16.4)
Insulin: Month 6 2.9  (25.4) -3.8  (23.9)
Oral hypoglycemic: Month 3 1.3  (12.6) 5  (51.3)
Oral hypoglycemic: Month 6 -0.5  (12.7) 6.4  (52.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Insulin-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.312
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5
Confidence Interval (2-Sided) 95%
-4.7 to 14.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Insulin-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.342
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
-5.0 to 14.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Severe Hypoglycemic Event Requiring Medical Intervention
Hide Description Severe hypoglycemia is defined by DCCT (Diabetes Control and Complications Trial) as any episode requiring external assistance to aid recovery or resulted in seizures or coma and included, as part of the definition, that the subject's blood glucose concentration had to have been documented as < 50mg/dL (<2.8mmol/L) for hypoglycemia, and/or the clinical manifestations had to have been reversed with oral carbohydrate, intramuscular glucagon, or intravenous glucose. Descriptive statistics were done, no inferential statistical analyses were performed.
Time Frame Baseline through Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population included all subjects randomized with a minimum of a baseline HbA1c value determined and one PD exchange using study solution performed. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 127 124
Measure Type: Number
Unit of Measure: events
1 3
4.Secondary Outcome
Title Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6
Hide Description Values for Total Cholesterol (TC), Low Density Lipoprotein Cholesterol (LDLC), High Density Lipoprotein Cholesterol (HDLC), Very Low Density Lipoprotein (VLDL), and Triglycerides are included. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 127 124
Mean (Standard Deviation)
Unit of Measure: mmol/L
Cholesterol: Month 3 Number Analyzed 127 participants 124 participants
0.1  (1.1) -0.5  (1.2)
Cholesterol: Month 6 Number Analyzed 127 participants 124 participants
0  (1.2) -0.4  (1.2)
LDLC: Month 3 Number Analyzed 127 participants 124 participants
0.1  (1.0) -0.2  (1.1)
LDLC: Month 6 Number Analyzed 127 participants 124 participants
0.1  (1.1) -0.1  (1.2)
HDLC: Month 3 Number Analyzed 127 participants 124 participants
0  (0.2) 0  (0.3)
HDLC: Month 6 Number Analyzed 127 participants 124 participants
0  (0.3) 0  (0.3)
VLDL: Month 3 Number Analyzed 126 participants 124 participants
-0.1  (0.9) -0.3  (0.8)
VLDL: Month 6 Number Analyzed 126 participants 124 participants
-0.1  (0.8) -0.3  (0.9)
Triglycerides: Month 3 Number Analyzed 127 participants 124 participants
-0.1  (1.9) -0.7  (1.8)
Triglycerides: Month 6 Number Analyzed 127 participants 124 participants
-0.3  (1.9) -0.6  (1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.5
Confidence Interval (2-Sided) 95%
0.1 to 0.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Cholesterol-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0 to 0.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-0.1 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for LDLC-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.593
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.198
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.1
Confidence Interval (2-Sided) 95%
-0.2 to 0
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for HDLC-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.298
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-0.1 to 0
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.2 to 0.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for VLDL-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
0.1 to 0.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.8
Confidence Interval (2-Sided) 95%
0.4 to 1.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Triglycerides-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
0.3 to 1.1
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6
Hide Description Values for Lipoprotein A (Lp(a)), Apolipoprotein A1 (Apo A1), and Apolipoprotein B (Apo B) are included. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 119 120
Mean (Standard Deviation)
Unit of Measure: mg/dL
Lp(a): Month 3 Number Analyzed 118 participants 120 participants
2.3  (8.9) 3.3  (9.8)
Lp(a): Month 6 Number Analyzed 118 participants 120 participants
6.7  (15.4) 6.8  (18)
Apo A1: Month 3 Number Analyzed 119 participants 120 participants
-2.1  (16.4) -9.3  (17.5)
Apo A1: Month 6 Number Analyzed 119 participants 120 participants
-3.8  (17.7) -10.5  (18.4)
Apo B: Month 3 Number Analyzed 119 participants 120 participants
5.3  (24.2) -8.5  (18.4)
Apo B: Month 6 Number Analyzed 119 participants 120 participants
5.2  (25.4) -3.6  (23.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.485
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.3
Confidence Interval (2-Sided) 95%
-8.6 to 4.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Lp(a)-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-8.2 to 4.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.101
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
-1.1 to 12.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Apo A1-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.134
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5
Confidence Interval (2-Sided) 95%
-1.5 to 11.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.4
Confidence Interval (2-Sided) 95%
3.6 to 19.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Apo B-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 8.4
Confidence Interval (2-Sided) 95%
0.8 to 15.9
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6
Hide Description Values for Insulin and C-peptide are included. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 119 120
Mean (Standard Deviation)
Unit of Measure: pg/mL
Insulin: Month 3 70.3  (514.2) 69.4  (809.4)
Insulin: Month 6 146.3  (616) 96.6  (1301.9)
C-peptide: Month 3 340.8  (2393.7) 70.5  (2687.2)
C-peptide: Month 6 388.3  (2660.5) 504.1  (2462.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.655
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -56.5
Confidence Interval (2-Sided) 95%
-304.6 to 191.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Insulin-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.811
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -29.2
Confidence Interval (2-Sided) 95%
-268.9 to 210.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.419
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 441.3
Confidence Interval (2-Sided) 95%
-630.4 to 1513.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for C-Peptide-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.820
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 121.8
Confidence Interval (2-Sided) 95%
-927.9 to 1171.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6
Hide Description Values for Pro-Insulin are provided. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluable subset of ITT population that had blood draw at baseline for these lab parameters were used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 119 120
Mean (Standard Deviation)
Unit of Measure: pmol/L
Pro-Insulin: Month 3 -1.8  (19.6) 13  (71.3)
Pro-Insulin: Month 6 3  (41.9) 0.4  (33.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.721
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.2
Confidence Interval (2-Sided) 95%
-27.5 to 19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Pro-Insulin-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 13.5
Confidence Interval (2-Sided) 95%
-9.4 to 36.4
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6
Hide Description Nutritional Status by SGA include the following: (a) Weight change over 6 months, (b) dietary history of food intake over the previous 24-hour period with a determination by the subject as to whether this was a typical or atypical diet for the subject, (c) significant and sustained gastrointestinal distress, (d) functional status, (e) metabolic stress including frequent infections, fever, peritonitis, uncontrolled diabetes and active inflammatory bowel disease. The SGA used a 7-point scale, where a decrease score in the change from baseline shows signs of increased malnourishment, and an increased score (e.g., +2) is improved nourishment. Scale: 6 - 7 = very mild risk to well-nourished; 3 - 5 = no clear sign of normal status or severe malnutrition; 1 - 2 = severely malnourished
Time Frame Baseline and Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 120 104
Measure Type: Number
Unit of Measure: participants
+2 Score 1 2
+1 Score 19 24
0 Score 76 57
-1 Score 20 17
-2 Score 3 4
-3 Score 1 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimates of Ratio-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.624
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.89
Confidence Interval (2-Sided) 95%
0.55 to 1.43
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6
Hide Description Values for Albumin and Total Protein are included. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 127 124
Mean (Standard Deviation)
Unit of Measure: g/L
Albumin: Month 3 -0.1  (3.1) -0.6  (3.6)
Albumin: Month 6 0.5  (3) -0.8  (3.9)
Total Protein: Month 3 0.1  (4.3) 0.2  (5.1)
Total Protein: Month 6 0.7  (4.9) -0.9  (6.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.338
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
-0.6 to 1.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Albumin-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
0.1 to 2.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.817
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-1.9 to 1.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Total Protein-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
-0.2 to 2.9
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6
Hide Description Values for Protein Nitrogen Appearance (PNA) and normalized protein nitrogen appearance (nPRNA) are included. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 79 79
Mean (Standard Deviation)
Unit of Measure: g/kg/day
PNA: Month 3 -0.8  (14.1) 12.8  (14.4)
PNA: Month 6 1  (18.6) 12.9  (17.5)
nPNA: Month 3 0  (0.2) 0.2  (0.2)
nPNA: Month 6 0  (0.3) 0.2  (0.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.127
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.2
Confidence Interval (2-Sided) 95%
-23.3 to 2.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for PNA-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -10.3
Confidence Interval (2-Sided) 95%
-16.4 to -4.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.4 to -0.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for nPNA-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.3 to -0.1
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6
Hide Description Values for Pre-albumin are included. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 83 85
Mean (Standard Deviation)
Unit of Measure: mg/dL
Month 3 0.4  (7.2) -1.9  (5.5)
Month 6 -1.0  (8.3) -2.9  (5.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.2
Confidence Interval (2-Sided) 95%
0.5 to 5.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Pre-Albumin-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3
Confidence Interval (2-Sided) 95%
0.5 to 5.6
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6
Hide Description Values for Drained Body Weight are included. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 127 124
Mean (Standard Deviation)
Unit of Measure: kg
Month 3 -0.2  (4.5) -0.2  (3.5)
Month 6 0.2  (5.2) -0.7  (3.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.884
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-3.9 to 3.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Drained Fat-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.716
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-3 to 4.3
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6
Hide Description Values for BMI are included. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 127 124
Mean (Standard Deviation)
Unit of Measure: kg/m2
Month 3 -0.1  (1.5) -0.1  (1.3)
Month 6 0.1  (1.9) -0.3  (1.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.961
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-1.2 to 1.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for BMI-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.581
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.8 to 1.5
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6
Hide Description Values for Waist Circumference are included. 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.
Time Frame Baseline, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 123 122
Mean (Standard Deviation)
Unit of Measure: cm
0  (6.4) 0.4  (5.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Waist Circumference-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.871
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-3.7 to 3.1
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6
Hide Description Values for Protein and Calories are included. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
Subset of ITT population that had evaluable data. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 91 87
Mean (Standard Deviation)
Unit of Measure: grams
Protein: Month 3 -5.6  (14.1) -4.9  (45.3)
Protein: Month 6 -0.1  (24.8) 4.5  (32.9)
Calories: Month 3 -76.8  (316.9) -199.1  (525.1)
Calories: Month 6 30.9  (589.5) 108  (654)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.608
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.2
Confidence Interval (2-Sided) 95%
-14.7 to 25
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Protein-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.731
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.7
Confidence Interval (2-Sided) 95%
-11.5 to 8.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.377
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 185.3
Confidence Interval (2-Sided) 95%
-227.5 to 598.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Calories-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.854
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -18.3
Confidence Interval (2-Sided) 95%
-214.4 to 177.8
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6
Hide Description European Quality of Life, 5 Dimensions (EQ-5D) generates a single index score based on a descriptive system that defines health in terms of 5 dimensions, consisting of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The possible range for each dimension is 1 to 3, where 1=no problems, 2=moderate problems, 3=extreme problems. Higher score implies more problems (worsening). According to this classification, 243 potential health states are defined. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 127 124
Mean (Standard Deviation)
Unit of Measure: Percent Change
Month 3 -0.01  (0.18) -0.04  (0.19)
Month 6 -0.04  (0.19) -0.03  (0.17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.412
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.03 to 0.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Questionnaire Index-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.485
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.07 to 0.03
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6
Hide Description Visual analogue scale to generate a self-perceived rating of health status. Visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 127 124
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Month 3 -2.33  (23.37) -2.58  (27.14)
Month 6 -1.60  (24.02) 0.92  (30.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.525
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.18
Confidence Interval (2-Sided) 95%
-4.56 to 8.93
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for EQ 5D Quest Health Status-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.995
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-6.79 to 6.83
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6
Hide Description The Diabetes Symptoms Checklist was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5="extremely" to 1="not at all." For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychological fatigue, psychological cognitive, neurology pain, neurology sensory, cardiology, ophthalmology, hypoglycemia, hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. 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.
Time Frame Baseline, Month 3, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population used. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 127 124
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Psychology, fatigue: Month 3 2.34  (20.73) 2.39  (20.33)
Psychology, fatigue: Month 6 2.48  (22.95) -0.49  (24.64)
Psychology, cognitive: Month 3 0.16  (18.54) 2.66  (18.38)
Psychology, cognitive: Month 6 2.23  (18.87) 1.70  (17.23)
Neurology, pain: Month 3 -3.46  (17.87) 0.32  (19.18)
Neurology, pain: Month 6 -1.57  (21.09) -1.75  (22.34)
Neurology, sensory: Month 3 -2.25  (16.96) 0.55  (16.09)
Neurology, sensory: Month 6 -0.19  (17.15) -3.59  (15.76)
Cardiology: Month 3 1.18  (17.32) 0.87  (15.84)
Cardiology: Month 6 3.60  (17.74) 0.29  (18.11)
Ophthalmology: Month 3 1.53  (21.98) 2.24  (19.71)
Ophthalmology: Month 6 -0.26  (24.53) 0.23  (19.43)
Hypoglycemia: Month 3 0.49  (20.72) 0.12  (21.02)
Hypoglycemia: Month 6 0.50  (22.25) -1.62  (21.72)
Hyperglycemia: Month 3 -2.07  (17.38) -1.79  (18.83)
Hyperglycemia: Month 6 -0.79  (19.50) -2.82  (18.25)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.87
Confidence Interval (2-Sided) 95%
-7.64 to 3.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Psychology Fatigue-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.779
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
-5.01 to 6.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.246
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.95
Confidence Interval (2-Sided) 95%
-7.95 to 2.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Psychology Cognitive-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.780
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.72
Confidence Interval (2-Sided) 95%
-5.78 to 4.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.885
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
-5.22 to 6.04
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Neurology Pain-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.41
Confidence Interval (2-Sided) 95%
-1.28 to 10.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.701
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
-4.40 to 6.54
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Neurology Sensory-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.21
Confidence Interval (2-Sided) 95%
1.70 to 12.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.934
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.20
Confidence Interval (2-Sided) 95%
-4.63 to 5.03
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Cardiology-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.209
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.13
Confidence Interval (2-Sided) 95%
-1.75 to 8.01
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.585
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.89
Confidence Interval (2-Sided) 95%
-4.90 to 8.68
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Ophthalmology-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.641
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.62
Confidence Interval (2-Sided) 95%
-5.22 to 8.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.586
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.50
Confidence Interval (2-Sided) 95%
-6.89 to 3.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Hypoglycemia-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.906
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-5.79 to 5.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 3
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.970
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-4.93 to 4.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Hyperglycemia-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.340
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.38
Confidence Interval (2-Sided) 95%
-2.52 to 7.28
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Change From Baseline of MRI Body Composition at Month 6
Hide Description Values for Abdominal Subcutaneous Fat Volume and Abdominal Visceral Fat Volume are included. 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.
Time Frame Baseline, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used in this analysis. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 39 43
Mean (Standard Deviation)
Unit of Measure: mL
Abdominal Visceral Fat Volume: Month 6 Number Analyzed 38 participants 43 participants
-49  (81.7) -64.8  (73.2)
Abdominal Subcutaneous Fat Volume: Month 6 Number Analyzed 39 participants 43 participants
-12  (58.9) -3.3  (70.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Abdominal Subcutaneous Fat Volume-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.495
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 24.6
Confidence Interval (2-Sided) 95%
-46.9 to 96
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for Abdominal Visceral Fat Volume-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.081
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 55.4
Confidence Interval (2-Sided) 95%
-7 to 117.8
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6
Hide Description Values for Left Ventricular (LV) End Diastolic and Systolic Volume are included. 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.
Time Frame Baseline, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT of MRI sub-study (n=88 consented to participate),however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 39 43
Mean (Standard Deviation)
Unit of Measure: mL
LV End Diastolic Volume 2.1  (35.5) 0.7  (28.4)
LV End Systolic Volume 3.3  (28.1) -0.2  (28.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for LV End Diastolic Volume-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.626
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.3
Confidence Interval (2-Sided) 95%
-19.3 to 31.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for LV End Systolic Volume-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.486
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.8
Confidence Interval (2-Sided) 95%
-14.5 to 30.1
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6
Hide Description Values for Left Ventricular (LV) Mass Without and With Pap Muscles are included. 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.
Time Frame Baseline, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 39 43
Mean (Standard Deviation)
Unit of Measure: grams
LV Mass Without Pap Muscles 0.6  (38.4) 3.3  (26.5)
LV Mass With Pap Muscles 1.1  (39.2) 3.5  (26.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for LV Mass with Pap Muscles-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.832
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.3
Confidence Interval (2-Sided) 95%
-18.9 to 23.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for LV Mass without Pap Muscles-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.820
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.4
Confidence Interval (2-Sided) 95%
-18.3 to 23.1
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6
Hide Description Values for Left Ventricular (LV) Ejection Fraction are included. 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.
Time Frame Baseline, Month 6 (End of Study)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT of MRI sub-study (n=88 consented to participate), however, only a subset of MRI sub-study that had evaluable data were used.. The data in this outcome measure is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067).
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description:
Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only
Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
Overall Number of Participants Analyzed 39 42
Mean (Standard Deviation)
Unit of Measure: Percent
-0.3  (8.2) 0.9  (10.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Non-Glucose Sparing Prescriptions, Glucose Sparing Prescriptions
Comments Estimate of Least Square Means Comparing Treatment Groups for LV Ejection Fraction-Month 6
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.955
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-6.9 to 6.5
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The data represented in this module is a pooled analysis of the following 3 studies: NCT00567489 (protocol ID 31998), NCT00567398 (protocol ID 34202), NCT01219959 (protocol ID51067). Given that the glucose content of the PD solutions is similar, the pooling of the results were considered a valid method to answer the underlying research questions.
 
Arm/Group Title Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Hide Arm/Group Description Dianeal only and/or Bieffe peritoneal dialysis (PD) solutions only Physioneal, Extraneal, Nutrineal (PEN) used for 31998 and 34202 studies, and Dianeal, Extraneal, Nutrineal (DEN) used for 51067 study.
All-Cause Mortality
Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Affected / at Risk (%) Affected / at Risk (%)
Total   41/127 (32.28%)   58/124 (46.77%) 
Blood and lymphatic system disorders     
Anaemia  1  2/127 (1.57%)  2/124 (1.61%) 
Cardiac disorders     
Acute Coronary Syndrome  1  0/127 (0.00%)  1/124 (0.81%) 
Acute Myocardial Infarction  1  1/127 (0.79%)  0/124 (0.00%) 
Angina Pectoris  1  2/127 (1.57%)  0/124 (0.00%) 
Cardiac Arrest  1  0/127 (0.00%)  1/124 (0.81%) 
Cardiac Failure Acute  1  1/127 (0.79%)  2/124 (1.61%) 
Cardiorespiratory Arrest  1  0/127 (0.00%)  1/124 (0.81%) 
Congestive Heart Failure  1  0/127 (0.00%)  1/124 (0.81%) 
Coronary Artery Disease  1  1/127 (0.79%)  1/124 (0.81%) 
Heart Failure  1  0/127 (0.00%)  1/124 (0.81%) 
Ischemic Heart Disease  1  1/127 (0.79%)  0/124 (0.00%) 
Ear and labyrinth disorders     
Deafness Neurosensory  1  0/127 (0.00%)  1/124 (0.81%) 
Eye disorders     
Retinal Detachment  1  0/127 (0.00%)  1/124 (0.81%) 
Gastrointestinal disorders     
Abdominal Discomfort  1  1/127 (0.79%)  0/124 (0.00%) 
Abdominal Pain  1  1/127 (0.79%)  1/124 (0.81%) 
Constipation  1  1/127 (0.79%)  1/124 (0.81%) 
Gastrointestinal Haemorrhage  1  0/127 (0.00%)  1/124 (0.81%) 
Gastrooesophageal Reflux Disease  1  0/127 (0.00%)  1/124 (0.81%) 
Intestinal Obstruction  1  0/127 (0.00%)  1/124 (0.81%) 
Mallory-Weiss Syndrome  1  0/127 (0.00%)  1/124 (0.81%) 
Peritonitis  1  2/127 (1.57%)  3/124 (2.42%) 
Peritonitis Associated To Peritoneal Dialysis  1  0/127 (0.00%)  1/124 (0.81%) 
Peritonitis By Capd  1  1/127 (0.79%)  1/124 (0.81%) 
General disorders     
Asthenia  1  0/127 (0.00%)  1/124 (0.81%) 
Catheter Related Complication  1  2/127 (1.57%)  1/124 (0.81%) 
Catheter Site Haemorrhage  1  0/127 (0.00%)  1/124 (0.81%) 
General Physical Health Deterioration  1  1/127 (0.79%)  0/124 (0.00%) 
Generalised Oedema  1  1/127 (0.79%)  0/124 (0.00%) 
Multi-Organ Failure  1  1/127 (0.79%)  0/124 (0.00%) 
Non Specific Thoracic Pain  1  1/127 (0.79%)  0/124 (0.00%) 
Non-Cardiac Chest Pain  1  0/127 (0.00%)  1/124 (0.81%) 
Sudden Death  1  1/127 (0.79%)  0/124 (0.00%) 
Thoracic Pain  1  1/127 (0.79%)  0/124 (0.00%) 
Immune system disorders     
Hypersensitivity Icodextrin  1  0/127 (0.00%)  1/124 (0.81%) 
Infections and infestations     
Abdominal Abscess  1  0/127 (0.00%)  1/124 (0.81%) 
Abscess In Abdominal Wall  1  0/127 (0.00%)  1/124 (0.81%) 
Abscess Limb  1  0/127 (0.00%)  1/124 (0.81%) 
Bacterial Peritonitis  1  1/127 (0.79%)  1/124 (0.81%) 
Cellulitis  1  1/127 (0.79%)  3/124 (2.42%) 
Cellulitis Of Face  1  1/127 (0.79%)  0/124 (0.00%) 
Cellulitis With Soft Tissue Necrosis Of The Right Hand  1  1/127 (0.79%)  0/124 (0.00%) 
Entero Invasive Diarrhea  1  0/127 (0.00%)  1/124 (0.81%) 
Eschar In The Left Thigh Region  1  0/127 (0.00%)  1/124 (0.81%) 
Facial Abscess  1  1/127 (0.79%)  0/124 (0.00%) 
Fungal Peritonitis  1  2/127 (1.57%)  1/124 (0.81%) 
Gangrene  1  2/127 (1.57%)  0/124 (0.00%) 
Gastroenteritis  1  2/127 (1.57%)  2/124 (1.61%) 
Gastroenteritis Viral  1  1/127 (0.79%)  0/124 (0.00%) 
Infection  1  0/127 (0.00%)  1/124 (0.81%) 
Lower Respiratory Tract Infection  1  1/127 (0.79%)  0/124 (0.00%) 
Necrotising Fasciitis  1  0/127 (0.00%)  1/124 (0.81%) 
Nosocomial Pneumonia  1  0/127 (0.00%)  1/124 (0.81%) 
Peritonitis Bacterial  1  5/127 (3.94%)  8/124 (6.45%) 
Pneumonia  1  2/127 (1.57%)  2/124 (1.61%) 
Post Traumatic Cellulitis  1  0/127 (0.00%)  1/124 (0.81%) 
Right Basal Pneumonia  1  0/127 (0.00%)  2/124 (1.61%) 
Sepsis  1  2/127 (1.57%)  1/124 (0.81%) 
Thigh Abscess  1  0/127 (0.00%)  1/124 (0.81%) 
Upper Respiratory Tract Infection  1  1/127 (0.79%)  0/124 (0.00%) 
Urinary Tract Infection  1  3/127 (2.36%)  0/124 (0.00%) 
Vestibular Neuronitis  1  1/127 (0.79%)  0/124 (0.00%) 
Injury, poisoning and procedural complications     
Ankle Fracture  1  0/127 (0.00%)  1/124 (0.81%) 
Contusion  1  0/127 (0.00%)  1/124 (0.81%) 
Investigations     
Blood Glucose Abnormal  1  1/127 (0.79%)  0/124 (0.00%) 
Metabolism and nutrition disorders     
Calciphylaxis  1  0/127 (0.00%)  1/124 (0.81%) 
Dehydration  1  1/127 (0.79%)  1/124 (0.81%) 
Diabetic Foot  1  1/127 (0.79%)  1/124 (0.81%) 
Fluid Overload  1  3/127 (2.36%)  5/124 (4.03%) 
Fluid Retention  1  1/127 (0.79%)  0/124 (0.00%) 
Hypercalcaemia  1  2/127 (1.57%)  0/124 (0.00%) 
Hyperglycaemia  1  2/127 (1.57%)  1/124 (0.81%) 
Hypervolaemia  1  1/127 (0.79%)  1/124 (0.81%) 
Hypoglycaemia  1  0/127 (0.00%)  2/124 (1.61%) 
Hyponatraemia  1  0/127 (0.00%)  1/124 (0.81%) 
Severe Hypoglycemia  1  0/127 (0.00%)  1/124 (0.81%) 
Musculoskeletal and connective tissue disorders     
Gouty Arthritis  1  1/127 (0.79%)  0/124 (0.00%) 
Soft Tissue Necrosis  1  1/127 (0.79%)  0/124 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix Carcinoma  1  1/127 (0.79%)  0/124 (0.00%) 
Nervous system disorders     
Cerebral Haemorrhage  1  1/127 (0.79%)  0/124 (0.00%) 
Cerebral Ischaemia  1  1/127 (0.79%)  0/124 (0.00%) 
Cerebrovascular Accident  1  1/127 (0.79%)  0/124 (0.00%) 
Cognitive Disorder  1  0/127 (0.00%)  1/124 (0.81%) 
Convulsion  1  0/127 (0.00%)  1/124 (0.81%) 
Dizziness  1  1/127 (0.79%)  0/124 (0.00%) 
Hypertensive Encephalopathy  1  0/127 (0.00%)  2/124 (1.61%) 
Neurotoxicity  1  1/127 (0.79%)  0/124 (0.00%) 
Seizure  1  0/127 (0.00%)  1/124 (0.81%) 
Seizures  1  0/127 (0.00%)  1/124 (0.81%) 
Sensory Impairment  1  0/127 (0.00%)  1/124 (0.81%) 
Syncope  1  1/127 (0.79%)  1/124 (0.81%) 
Thalamic Infarction  1  0/127 (0.00%)  1/124 (0.81%) 
Transient Ischaemic Attack  1  1/127 (0.79%)  0/124 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pleural Effusion  1  0/127 (0.00%)  1/124 (0.81%) 
Pulmonary Edema  1  0/127 (0.00%)  2/124 (1.61%) 
Respiratory Arrest  1  0/127 (0.00%)  1/124 (0.81%) 
Skin and subcutaneous tissue disorders     
Decubitus Ulcer  1  0/127 (0.00%)  1/124 (0.81%) 
Diabetic Ulcer  1  1/127 (0.79%)  0/124 (0.00%) 
Erythema Multiforme  1  0/127 (0.00%)  1/124 (0.81%) 
Left Malleolus Ulcer  1  0/127 (0.00%)  1/124 (0.81%) 
Local Infection Of The Skin (Diabetic Sore)  1  1/127 (0.79%)  0/124 (0.00%) 
Rash  1  0/127 (0.00%)  1/124 (0.81%) 
Skin Ulcer  1  0/127 (0.00%)  1/124 (0.81%) 
Vascular disorders     
Blood Pressure Inadequately Controlled  1  1/127 (0.79%)  0/124 (0.00%) 
Hypertension  1  0/127 (0.00%)  1/124 (0.81%) 
Hypertensive Crisis  1  1/127 (0.79%)  3/124 (2.42%) 
Hypertensive Urgency  1  0/127 (0.00%)  1/124 (0.81%) 
Hypotension  1  1/127 (0.79%)  0/124 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-Glucose Sparing Prescriptions Glucose Sparing Prescriptions
Affected / at Risk (%) Affected / at Risk (%)
Total   101/127 (79.53%)   98/124 (79.03%) 
Blood and lymphatic system disorders     
Anaemia  1  6/127 (4.72%)  7/124 (5.65%) 
Anemia  1  2/127 (1.57%)  1/124 (0.81%) 
Cardiac disorders     
Acute Coronary Syndrome  1  0/127 (0.00%)  1/124 (0.81%) 
Acute Myocardial Infarction  1  1/127 (0.79%)  0/124 (0.00%) 
Angina Pectoris  1  2/127 (1.57%)  0/124 (0.00%) 
Arteriosclerosis Coronary Artery  1  1/127 (0.79%)  0/124 (0.00%) 
Cardiac Arrest  1  0/127 (0.00%)  1/124 (0.81%) 
Cardiac Failure Acute  1  1/127 (0.79%)  2/124 (1.61%) 
Cardiorespiratory Arrest  1  0/127 (0.00%)  1/124 (0.81%) 
Congestive Heart Failure  1  0/127 (0.00%)  1/124 (0.81%) 
Coronary Artery Disease  1  2/127 (1.57%)  1/124 (0.81%) 
Heart Failure  1  0/127 (0.00%)  1/124 (0.81%) 
Ischemic Heart Disease  1  1/127 (0.79%)  0/124 (0.00%) 
Left Atrial Enlargement  1  1/127 (0.79%)  1/124 (0.81%) 
Tachycardia  1  0/127 (0.00%)  1/124 (0.81%) 
Ventricular Extrasystoles  1  0/127 (0.00%)  1/124 (0.81%) 
Ear and labyrinth disorders     
Cerumen Impaction  1  1/127 (0.79%)  0/124 (0.00%) 
Deafness Neurosensory  1  1/127 (0.79%)  1/124 (0.81%) 
Ear Pain  1  0/127 (0.00%)  1/124 (0.81%) 
Endocrine disorders     
Hyperparathyroidism  1  2/127 (1.57%)  1/124 (0.81%) 
Hyperparathyroidism Secondary  1  1/127 (0.79%)  0/124 (0.00%) 
Hyperthyroidism  1  0/127 (0.00%)  1/124 (0.81%) 
Eye disorders     
Cataract  1  1/127 (0.79%)  0/124 (0.00%) 
Diabetic Retinopathy  1  0/127 (0.00%)  1/124 (0.81%) 
Dry Eye  1  2/127 (1.57%)  0/124 (0.00%) 
Eye Haemorrhage  1  1/127 (0.79%)  0/124 (0.00%) 
Eye Pain  1  1/127 (0.79%)  1/124 (0.81%) 
Eye Pruritus  1  0/127 (0.00%)  1/124 (0.81%) 
Glaucoma  1  1/127 (0.79%)  1/124 (0.81%) 
Myodesopsia  1  1/127 (0.79%)  0/124 (0.00%) 
Retinal Detachment  1  0/127 (0.00%)  1/124 (0.81%) 
Visual Acuity Reduced  1  1/127 (0.79%)  0/124 (0.00%) 
Vitreous Haemorrhage  1  0/127 (0.00%)  1/124 (0.81%) 
Gastrointestinal disorders     
Abdominal Discomfort  1  1/127 (0.79%)  0/124 (0.00%) 
Abdominal Distension  1  1/127 (0.79%)  1/124 (0.81%) 
Abdominal Pain  1  3/127 (2.36%)  5/124 (4.03%) 
Abdominal Pain Upper  1  0/127 (0.00%)  1/124 (0.81%) 
Acute Diarrhea  1  0/127 (0.00%)  1/124 (0.81%) 
Bloating  1  0/127 (0.00%)  1/124 (0.81%) 
Bloody Peritoneal Effluent  1  1/127 (0.79%)  0/124 (0.00%) 
Constipation  1  4/127 (3.15%)  8/124 (6.45%) 
Diabetic Gastropathy  1  1/127 (0.79%)  0/124 (0.00%) 
Diarrhea  1  2/127 (1.57%)  0/124 (0.00%) 
Diarrhoea  1  4/127 (3.15%)  1/124 (0.81%) 
Dyspepsia  1  0/127 (0.00%)  3/124 (2.42%) 
Epigastric Pain  1  2/127 (1.57%)  0/124 (0.00%) 
Gastric Ulcer Haemorrhage  1  1/127 (0.79%)  0/124 (0.00%) 
Gastritis  1  0/127 (0.00%)  1/124 (0.81%) 
Gastroduodenitis  1  0/127 (0.00%)  1/124 (0.81%) 
Gastrointestinal Haemorrhage  1  0/127 (0.00%)  1/124 (0.81%) 
Gastrooesophageal Reflux Disease  1  0/127 (0.00%)  1/124 (0.81%) 
Hyperemesis  1  1/127 (0.79%)  0/124 (0.00%) 
Impaired Gastric Emptying  1  1/127 (0.79%)  0/124 (0.00%) 
Inguinal Hernia  1  0/127 (0.00%)  1/124 (0.81%) 
Intestinal Obstruction  1  0/127 (0.00%)  1/124 (0.81%) 
Mallory-Weiss Syndrome  1  0/127 (0.00%)  2/124 (1.61%) 
Nausea  1  6/127 (4.72%)  4/124 (3.23%) 
Nauseas  1  0/127 (0.00%)  1/124 (0.81%) 
Odynophagia  1  0/127 (0.00%)  1/124 (0.81%) 
Pain In Teeth  1  0/127 (0.00%)  1/124 (0.81%) 
Peptic Ulcer  1  1/127 (0.79%)  0/124 (0.00%) 
Peritoneal Haemorrhage  1  0/127 (0.00%)  1/124 (0.81%) 
Peritonitis  1  10/127 (7.87%)  10/124 (8.06%) 
Peritonitis Associated To Peritoneal Dialysis  1  0/127 (0.00%)  1/124 (0.81%) 
Peritonitis By Cap  1  1/127 (0.79%)  0/124 (0.00%) 
Peritonitis By Capd  1  1/127 (0.79%)  2/124 (1.61%) 
Reflux Oesophagitis  1  0/127 (0.00%)  1/124 (0.81%) 
Umbilical Hernia  1  1/127 (0.79%)  1/124 (0.81%) 
Vomiting  1  4/127 (3.15%)  9/124 (7.26%) 
General disorders     
Application Site Oedema  1  0/127 (0.00%)  1/124 (0.81%) 
Asthenia  1  0/127 (0.00%)  4/124 (3.23%) 
Catheter Related Complication  1  4/127 (3.15%)  4/124 (3.23%) 
Catheter Site Discharge  1  1/127 (0.79%)  1/124 (0.81%) 
Catheter Site Haemorrhage  1  0/127 (0.00%)  1/124 (0.81%) 
Chest Discomfort  1  1/127 (0.79%)  1/124 (0.81%) 
Chills  1  0/127 (0.00%)  1/124 (0.81%) 
General Physical Health Deterioration  1  1/127 (0.79%)  0/124 (0.00%) 
Generalised Oedema  1  1/127 (0.79%)  0/124 (0.00%) 
Granuloma  1  1/127 (0.79%)  0/124 (0.00%) 
Granuloma In Exit-Site  1  0/127 (0.00%)  1/124 (0.81%) 
Granuloma Of The Exit Site  1  0/127 (0.00%)  1/124 (0.81%) 
Influenza Like Illness  1  0/127 (0.00%)  1/124 (0.81%) 
Injection Site Papule  1  1/127 (0.79%)  0/124 (0.00%) 
Mild Erythema Of Catheter Exit Site  1  0/127 (0.00%)  1/124 (0.81%) 
Multi-Organ Failure  1  1/127 (0.79%)  0/124 (0.00%) 
Non Specific Thoracic Pain  1  1/127 (0.79%)  0/124 (0.00%) 
Non-Cardiac Chest Pain  1  0/127 (0.00%)  1/124 (0.81%) 
Oedema  1  8/127 (6.30%)  0/124 (0.00%) 
Oedema Peripheral  1  10/127 (7.87%)  2/124 (1.61%) 
Peritoneal Catheter Dysfunction  1  1/127 (0.79%)  0/124 (0.00%) 
Pyrexia  1  0/127 (0.00%)  2/124 (1.61%) 
Sickness  1  1/127 (0.79%)  1/124 (0.81%) 
Sudden Death  1  1/127 (0.79%)  0/124 (0.00%) 
Thirst  1  1/127 (0.79%)  0/124 (0.00%) 
Thoracic Pain  1  1/127 (0.79%)  0/124 (0.00%) 
Xerosis  1  1/127 (0.79%)  0/124 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/127 (0.79%)  0/124 (0.00%) 
Hepatitis Toxic  1  0/127 (0.00%)  1/124 (0.81%) 
Immune system disorders     
Hypersensitivity Icodextrin  1  0/127 (0.00%)  1/124 (0.81%) 
Skin Allergic Reaction  1  0/127 (0.00%)  1/124 (0.81%) 
Infections and infestations     
Abdominal Abscess  1  0/127 (0.00%)  1/124 (0.81%) 
Abscess In Abdominal Wall  1  0/127 (0.00%)  1/124 (0.81%) 
Abscess Limb  1  0/127 (0.00%)  1/124 (0.81%) 
Bacterial Peritonitis  1  2/127 (1.57%)  1/124 (0.81%) 
Candidiasis  1  0/127 (0.00%)  1/124 (0.81%) 
Catheter Site Infection  1  5/127 (3.94%)  5/124 (4.03%) 
Cellulitis  1  1/127 (0.79%)  3/124 (2.42%) 
Cellulitis Of Face  1  1/127 (0.79%)  0/124 (0.00%) 
Cellulitis With Soft Tissue Necrosis Of The Right Hand  1  1/127 (0.79%)  0/124 (0.00%) 
Diarrhoea Infectious  1  0/127 (0.00%)  1/124 (0.81%) 
Entero Invasive Diarrhea  1  0/127 (0.00%)  1/124 (0.81%) 
Eschar In The Left Thigh Region  1  0/127 (0.00%)  1/124 (0.81%) 
Exit Site Infection  1  1/127 (0.79%)  1/124 (0.81%) 
Exit Site Infection Of Catheter  1  0/127 (0.00%)  1/124 (0.81%) 
Facial Abscess  1  1/127 (0.79%)  0/124 (0.00%) 
Flu  1  2/127 (1.57%)  2/124 (1.61%) 
Folliculitis  1  0/127 (0.00%)  1/124 (0.81%) 
Fungal Peritonitis  1  2/127 (1.57%)  1/124 (0.81%) 
Gangrene  1  2/127 (1.57%)  0/124 (0.00%) 
Gastroenteritis  1  3/127 (2.36%)  2/124 (1.61%) 
Gastroenteritis Viral  1  1/127 (0.79%)  0/124 (0.00%) 
Herpes Virus Infection  1  0/127 (0.00%)  1/124 (0.81%) 
Herpes Zoster  1  2/127 (1.57%)  1/124 (0.81%) 
Infection  1  0/127 (0.00%)  1/124 (0.81%) 
Localised Infection  1  0/127 (0.00%)  1/124 (0.81%) 
Lower Respiratory Tract Infection  1  2/127 (1.57%)  2/124 (1.61%) 
Nasopharyngitis  1  0/127 (0.00%)  2/124 (1.61%) 
Necrotising Fasciitis  1  0/127 (0.00%)  1/124 (0.81%) 
Nosocomial Pneumonia  1  0/127 (0.00%)  1/124 (0.81%) 
Oral Herpes  1  0/127 (0.00%)  1/124 (0.81%) 
Orchitis  1  1/127 (0.79%)  0/124 (0.00%) 
Otitis Externa  1  1/127 (0.79%)  0/124 (0.00%) 
Peritonitis Bacterial  1  7/127 (5.51%)  8/124 (6.45%) 
Pharyngitis  1  0/127 (0.00%)  1/124 (0.81%) 
Pneumonia  1  3/127 (2.36%)  2/124 (1.61%) 
Post Traumatic Cellulitis  1  0/127 (0.00%)  1/124 (0.81%) 
Respiratory Tract Infection Viral  1  1/127 (0.79%)  0/124 (0.00%) 
Rhinitis  1  0/127 (0.00%)  1/124 (0.81%) 
Right Basal Pneumonia  1  0/127 (0.00%)  2/124 (1.61%) 
Sepsis  1  2/127 (1.57%)  1/124 (0.81%) 
Severe Acute Respiratory Syndrome  1  1/127 (0.79%)  0/124 (0.00%) 
Skin Infection  1  0/127 (0.00%)  1/124 (0.81%) 
Skin Infection Staphylococcus  1  0/127 (0.00%)  1/124 (0.81%) 
Syphilis  1  1/127 (0.79%)  0/124 (0.00%) 
Thigh Abscess  1  0/127 (0.00%)  1/124 (0.81%) 
Tonsillitis  1  1/127 (0.79%)  0/124 (0.00%) 
Upper Respiratory Tract Infection  1  2/127 (1.57%)  4/124 (3.23%) 
Urinary Infection  1  0/127 (0.00%)  1/124 (0.81%) 
Urinary Tract Infection  1  6/127 (4.72%)  2/124 (1.61%) 
Vestibular Neuronitis  1  1/127 (0.79%)  0/124 (0.00%) 
Viral Infection  1  0/127 (0.00%)  1/124 (0.81%) 
Vulvovaginal Candidiasis  1  0/127 (0.00%)  1/124 (0.81%) 
Wound Infection  1  1/127 (0.79%)  0/124 (0.00%) 
Injury, poisoning and procedural complications     
Ankle Fracture  1  0/127 (0.00%)  1/124 (0.81%) 
Bitten By A Dog On The Left Leg  1  1/127 (0.79%)  0/124 (0.00%) 
Contusion  1  0/127 (0.00%)  1/124 (0.81%) 
Dialysis Device Complication  1  0/127 (0.00%)  1/124 (0.81%) 
Excoriation  1  0/127 (0.00%)  1/124 (0.81%) 
Excoriation On Knees  1  1/127 (0.79%)  0/124 (0.00%) 
Fracture Right Leg  1  1/127 (0.79%)  0/124 (0.00%) 
Incisional Hernia  1  2/127 (1.57%)  0/124 (0.00%) 
Joint Sprain  1  0/127 (0.00%)  1/124 (0.81%) 
Trauma Of Soft Tissue  1  0/127 (0.00%)  1/124 (0.81%) 
Investigations     
Blood Alkaline Phosphatase Increased  1  1/127 (0.79%)  0/124 (0.00%) 
Blood Calcium Decreased  1  1/127 (0.79%)  0/124 (0.00%) 
Blood Glucose Abnormal  1  1/127 (0.79%)  0/124 (0.00%) 
Blood Magnesium Decreased  1  1/127 (0.79%)  0/124 (0.00%) 
Blood Parathyroid Hormone Increased  1  2/127 (1.57%)  0/124 (0.00%) 
Blood Phosphorus Decreased  1  0/127 (0.00%)  1/124 (0.81%) 
Blood Urea Increased  1  1/127 (0.79%)  0/124 (0.00%) 
Decreased Peripheral Pulses  1  0/127 (0.00%)  1/124 (0.81%) 
Electrocardiogram T Wave Inversion  1  2/127 (1.57%)  0/124 (0.00%) 
Fibrin Abnormal  1  0/127 (0.00%)  1/124 (0.81%) 
Haemoglobin Increased  1  1/127 (0.79%)  0/124 (0.00%) 
Heart Murmur  1  1/127 (0.79%)  0/124 (0.00%) 
Liver Function Test Abnormal  1  0/127 (0.00%)  1/124 (0.81%) 
St Segment Depression  1  1/127 (0.79%)  0/124 (0.00%) 
T Peaked  1  0/127 (0.00%)  1/124 (0.81%) 
Urine Output Decreased  1  1/127 (0.79%)  0/124 (0.00%) 
Weight Increased  1  0/127 (0.00%)  1/124 (0.81%) 
Metabolism and nutrition disorders     
Calciphylaxis  1  0/127 (0.00%)  1/124 (0.81%) 
Decreased Appetite  1