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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

Tracking Information
First Submitted Date  ICMJE December 4, 2007
First Posted Date  ICMJE December 5, 2007
Results First Submitted Date  ICMJE November 14, 2017
Results First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 3, 2019
Study Start Date  ICMJE April 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 4, 2007)
Change from the baseline value in HbA1c between the PPEN group compared to the DDDD group [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2007)
Glycemic control medication usage, hypoglycemic events, metabolic control, nutritional status, and QOL. [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IMPENDIA- PEN VS Dianeal Only Improved Metabolic Control In Diabetic CAPD and APD Patients
Official Title  ICMJE Multi-center,Prospective, Randomized Trial ToDemonstrate Improved Metabolic Control of PEN VS Dianeal In Diabetic CAPD and APD Patients - The Impendia Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • ESRD
  • Diabetes
Intervention  ICMJE
  • Drug: Dianeal
    Dianeal 1.5% Dextrose (1.38% Glucose), 2.5% Dextrose (2.27% Glucose), 4.25% Dextrose (3.86% Glucose)
  • Drug: Physioneal
    Physioneal 40 or Physioneal 35
  • Drug: Extraneal
    Extraneal - 7.5% Icodextrin
  • Drug: Nutrineal
    Nutrineal - 1.1% Amino Acids
Study Arms  ICMJE
  • Active Comparator: non glucose sparing
    Dianeal only
    Intervention: Drug: Dianeal
  • Experimental: Glucose sparing
    Physioneal, Extraneal, Nutrineal
    Interventions:
    • Drug: Physioneal
    • Drug: Extraneal
    • Drug: Nutrineal
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2017)
43
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2007)
236
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00567398
Other Study ID Numbers  ICMJE 34202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baxter Healthcare Corporation
Study Sponsor  ICMJE Baxter Healthcare Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Baxter Healthcare Corporation Call central contact for information
PRS Account Baxter Healthcare Corporation
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP