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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

Brief Summary:

Primary Objective: To demonstrate that use of glucose sparing prescriptions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD)and Automated Peritoneal Dialysis (APD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels.

Secondary Objectives: To demonstrate that use of glucose-sparing PD solutions (PEN vs Dianeal) in diabetic (Type 1 and Type 2) CAPD and APD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life. In a subgroup of patients, the impact of glucose-sparing PD solutions (PEN vs Dianeal only) on abdominal fat and left ventricular (LV) structure and function will be assessed.


Condition or disease Intervention/treatment Phase
ESRD Diabetes Drug: Dianeal Drug: Physioneal Drug: Extraneal Drug: Nutrineal Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-center,Prospective, Randomized Trial ToDemonstrate Improved Metabolic Control of PEN VS Dianeal In Diabetic CAPD and APD Patients - The Impendia Trial
Study Start Date : April 2008
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: non glucose sparing
Dianeal only
Drug: Dianeal
Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose)

Experimental: Glucose sparing
Physioneal, Extraneal, Nutrineal
Drug: Physioneal
Physioneal 40 or Physioneal 35

Drug: Extraneal
Extraneal - 7.5% Icodextrin

Drug: Nutrineal
Nutrineal - 1.1% Amino Acids




Primary Outcome Measures :
  1. Change From the Baseline Value in HbA1c at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  2. Number of Severe Hypoglycemic Event Requiring Medical Intervention [ Time Frame: Baseline through Month 6 (End of Study) ]
    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.

  3. Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  4. Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  5. Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  6. Change From Baseline of Metabolic Control Determined by Insulin Action of Pro-Insulin at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  7. Number of Participants by Change From Baseline Score in Subjective Global Assessment (SGA) Class at Month 6 [ Time Frame: Baseline and Month 6 (End of Study) ]
    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

  8. Change From Baseline of Nutritional Status Determined by Albumin and Total Protein (Labs) at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  9. Change From Baseline of Nutritional Status Determined by PNA and nPNA (Labs) at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  10. Change From Baseline of Nutritional Status Determined by Pre-albumin (Labs) at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  11. Change From Baseline of Nutritional Status Determined by Drained Body Weight at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  12. Change From Baseline of Nutritional Status Determined by Body Mass Index (BMI) at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  13. Change From Baseline of Nutritional Status Determined by Waist Circumference at Month 6 [ Time Frame: Baseline, Month 6 (End of Study) ]
    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.

  14. Change From Baseline of Nutritional Status Determined by Protein and Calories at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  15. Change From Baseline in QOL Based pm the EQ 5D Questionnaire Index at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  16. Change From Baseline in QOL Based on the EQ 5D Quest Health Status at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  17. Change From Baseline in QOL Based on the Diabetes Symptom Checklist (DSC) at Month 3 and 6 [ Time Frame: Baseline, Month 3, Month 6 (End of Study) ]
    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.

  18. Change From Baseline of MRI Body Composition at Month 6 [ Time Frame: Baseline, Month 6 (End of Study) ]
    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.

  19. Change From Baseline of Left Ventricular (LV) End Diastolic and Systolic Volume as Determined by MRI at Month 6 [ Time Frame: Baseline, Month 6 (End of Study) ]
    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.

  20. Change From Baseline of Left Ventricular (LV) Mass Without and With Pap Muscles as Determined by MRI at Month 6 [ Time Frame: Baseline, Month 6 (End of Study) ]
    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.

  21. Change From Baseline of Left Ventricular (LV) Ejection Fraction as Determined by MRI at Month 6 [ Time Frame: Baseline, Month 6 (End of Study) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. M/F patients 18 years of age or older
  2. Diagnosis of ESRD (GFR ≤ 15 mL/min)
  3. CAPD or APD using only Dianeal and/or Physioneal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
  4. DM (Type 1 and 2) on glycemic-control medication, for 90 days
  5. HbA1c > 6.0% but ≤ 12.0%
  6. Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL

Exclusion Criteria:

  1. Cardiovascular event within the last 90 days
  2. Ongoing clinically significant congestive heart failure (NYHA class III or IV)
  3. Allergy to starch-based polymers
  4. Glycogen storage disease
  5. Glycogen storage disease
  6. Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
  7. Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP < 77) at Screening.
  8. Serum urea > 30 mmol/L
  9. Receiving rosiglitazone maleate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00567398


Locations
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Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Liverpool Hospital
Sydney, New South Wales, Australia, 2170
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Princess Alexandra Hospital
Wolloongabba, Queensland, Australia, 4102
Australia, South Australia
Flinders Medical Centre
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Australia
Gold Coast Hospital
South Port, Australia, 4215
Canada, Manitoba
Saint Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, New Brunswick
Beausejour Hospital Corporation
Moncton, New Brunswick, Canada, E1A1J9
Canada, Ontario
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Royal Victoria Hospital
Montreal, Quebec, Canada
New Zealand
Auckland Hospital
Grafton, Auckland, New Zealand
Waikato DHB
Hamilton, Waikato, New Zealand
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
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Study Director: Baxter Healthcare Corporation Call central contact for information
Publications:
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00567398    
Other Study ID Numbers: 34202
First Posted: December 5, 2007    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Keywords provided by Baxter Healthcare Corporation:
ESRD
Diabetes
CAPD
APD
Additional relevant MeSH terms:
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Icodextrin
Dialysis Solutions
Pharmaceutical Solutions