Dianeal, Extraneal, Nutrineal (D-E-N) Versus Dianeal Only in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients

NCT01219959 | Completed Phase 3 Results DMC

• 1 other identifier: 51067
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 16

Brief Summary

Primary Objective: To demonstrate that use of glucose sparing prescriptions, Dianeal, Extraneal, Nutrineal (D-E-N) versus Dianeal only, in diabetic (Type 1 and Type 2) Continuous Ambulatory Peritoneal Dialysis (CAPD) patients leads to improved metabolic control as measured by the magnitude of change from the baseline value in the HbA1c levels. Secondary Objectives: To demonstrate that use of glucose-sparing Peritoneal Dialysis solutions (D-E-N versus Dianeal only) in diabetic (Type 1 and Type 2) CAPD patients leads to lower glycemic-control medication requirements, decreased incidence of severe hypoglycemic events requiring medical intervention, improved metabolic control, nutritional status, and Quality of Life.

Conditions

End Stage Renal Disease (ESRD); Diabetes; CAPD

Keywords

ESRD; Diabetes; CAPD

Outcome Measures

Primary Outcomes (1)

• Change From the Baseline Value in HbA1c at Month 3 and 6

  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.

  Baseline, Month 3, Month 6 (End of Study)

Secondary Outcomes (21)

• Change From Baseline in Glycemic Control Medication Usage at Month 3 and 6

  Baseline, Month 3, Month 6 (End of Study)

• Number of Severe Hypoglycemic Event Requiring Medical Intervention

  Baseline through Month 6 (End of Study)

• Change From Baseline of Metabolic Control Determined by Lipid Profile and Triglycerides at Month 3 and 6

  Baseline, Month 3, Month 6 (End of Study)

• Change From Baseline of Metabolic Control Determined by Lipoproteins at Month 3 and 6

  Baseline, Month 3, Month 6 (End of Study)

• Change From Baseline of Metabolic Control Determined by Insulin Action of Insulin and C-peptide at Month 3 and 6

  Baseline, Month 3, Month 6 (End of Study)

Study Arms (2)

Non-glucose Sparing

ACTIVE COMPARATOR

Dianeal only

Drug: Dianeal

Glucose Sparing

EXPERIMENTAL

Dianeal, Extraneal, Nutrineal

Drug: Dianeal, Extraneal, Nutrineal

Interventions

Dianeal DRUG

Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose

Non-glucose Sparing

Dianeal, Extraneal, Nutrineal DRUG

Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin

Glucose Sparing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female patients 18 years of age or older
• Diagnosis of ESRD \[Glomerular Filtration Rate (GFR) ≤ 15 mL/min\]
• CAPD using only Dianeal, at least 1 exchange of 2.5% or 4.25% dextrose/day, no prescribed dry time
• Diabetes Mellitus (Type 1 and 2)
• HbA1c \> 6.0% but ≤ 12.0%
• Blood hemoglobin ≥ 8.0 g/dL, but ≤ 13.0 g/dL
• Total Kt/V ≥ 1.7

You may not qualify if:

• Blood Urea Nitrogen (BUN) \> 95 mg/dL
• Exposure to Extraneal within 60 days of Screening
• Mean Arterial Pressure (MAP) ≥ 125 mm Hg, or volume depleted (MAP \< 77mm Hg) at Screening
• Peritonitis, exit-site or tunnel infection treated with antibiotics within last 30 days
• Cardiovascular event within the last 30 days
• Ongoing clinically significant congestive heart failure \[New York Heart Association (NYHA) class III or IV\]
• Allergy to starch-based polymers, glycogen storage disease or isomaltose/maltose intolerance
• Receiving rosiglitazone maleate

Sponsors & Collaborators

• Vantive Health LLC: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (16)

Nefrosalud Ltda

Armenia, Colombia

Location

RTS Ltda Barranquila

Barranquilla, Colombia

Location

RTS Ltda Soledad

Bogotá, Colombia

Location

Rts Ltda Ag H.U.S

Bucaramanga, Colombia

Location

RTS Ltda H.U.V

Cali, Colombia

Location

RTS Ltda STR del Valle

Cali, Colombia

Location

RTS Ltda Versalles

Cali, Colombia

Location

Renal Therapy Services (RTS) Ltda Cartagena

Cartagena, Colombia

Location

RTS Ltda Cucuta

Cúcuta, Colombia

Location

RTS Ltda Girardot

Girardot, Colombia

Location

Unidad Renal de Tolima

Ibagué, Colombia

Location

RTS Ltda Sucursal Medellin

Medellín, Colombia

Location

RTS Ltda Valle de Aburra

Medellín, Colombia

Location

RTS Ltda Sogamoso

Sogamoso, Colombia

Location

RTS Sucrusal Tulua

Tuluá, Colombia

Location

RTS Ltda Villavicencio

Villavicencio, Colombia

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Diabetes Mellitus

Interventions

Icodextrin; Nutrineal

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

Limitations and Caveats

This is a pooled analysis of NCT00567489, NCT00567398, and NCT01219959. Given that the glucose content of the PD solutions were similar, the pooling of the results were considered a valid method to answer the underlying research questions.

Results Point of Contact

• Title: Global CORP Clinical Trials Disclosure
• Organization: Vantive

Global.CORP.ClinicalTrialsDisclosure@vantive.com

+1 2249484283

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 13, 2010
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: July 24, 2025
• Results First Posted: June 3, 2019

Record last verified: 2025-07

Locations

CO (16)