Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by:
Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT00286962
First received: February 3, 2006
Last updated: April 10, 2008
Last verified: April 2008
  Purpose

The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous administration of insulin regarding safety, glycemic control and number of episodes of hypoglycemia in patients with type 1 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Device: MIP 2007C implantable insulin pump
Device: continuous subcutaneous insulin infusion (CSII) or MDI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Cross-Over Single Centre Study Comparing the Effects of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus Patients

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • incidence of hypoglycemia; data taken from patient diaries during either study arm. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • glycemic control; glycosylated hemoglobin (HbA1c) measurement at baseline, end of entry phase, start of both study arms, halfway through study arms, end of study arms.
  • average daily insulin usage; as taken from patient diaries for both study arms
  • frequency of adverse events; as taken from patient diaries for both study arms
  • frequency of clinically significant abnormal laboratory values and device complications; as taken from patient diaries for both study arms
  • Quality of life; score on a quality of life scale at baseline and end of either study arm
  • Treatment satisfaction; score on treatment satisfaction scale at baseline and end of either study arm
  • daily glucose excursions; measured with continuous glucose monitoring system (CGMS) at baseline, halfway through and at the end of both study arms

Enrollment: 24
Study Start Date: February 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CIPII
Intraperitoneal insulin infusion by means of an implanted insulin pump
Device: MIP 2007C implantable insulin pump
Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c
Active Comparator: CSII/ MDI
Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII) or by multiple daily injections (MDI)
Device: continuous subcutaneous insulin infusion (CSII) or MDI

Detailed Description:

Various study data available suggest that intraperitoneal (IP) delivery of insulin in type 1 and type 2 diabetic subjects provides an appropriate therapy that allows subjects to achieve acceptable glycemic control without increasing the inherent risk of severe hypoglycemia observed when intensive insulin treatment is pursued. Up till now little research has been done to investigate the efficacy of intraperitoneal (IP) therapy compared to subcutaneous administration. In this study we aim for safety and non-inferiority or superiority for IP therapy concerning glycemic control with less episodes of hypoglycemia compared to intensive subcutaneous (SC) therapy in intermediate or poorly controlled Type 1 patients and/or patients with frequent severe hypoglycemic events.

Subjects will be randomized to insulin treatment using the Medtronic Minimed Implantable Pump or to subcutaneous insulin therapy during the first study arm. After the first arm of the study, subjects will be crossed over to the second arm and will receive the treatment whichever they had not received in the first treatment phase. Subjects with the MIP already implanted will retain the pump but will receive diluent intraperitoneally for the second study arm.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus
  • Intermediate or poor glycemic control, defined as HbA1c ≥ 7,5% AND/OR ≥ 5 incidents of hypoglycemia a week.

Exclusion Criteria:

  • renal function impairment: creatinin ≥ 150 micromol/L or a creatinin clearance < 50 ml/min
  • Cardiac problems: decompensated heart failure (NYHA III and IV); diagnosis of unstable angina pectoris; myocardial infarction within the last 12 months
  • Known or suspected allergy against insulin or any component of the composition
  • Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past.
  • Severe untreated proliferative retinopathy.
  • Insufficient knowledge of the Dutch language to understand the requirements of the study.
  • Current use of systemic corticosteroids or suffering from a condition which caused systemic corticosteroid use more than once in the last year.
  • Substance abuse, other than nicotine
  • A history of cancer, excluding well differentiated thyroid carcinoma, breast carcinoma without lymph node metastases and skin carcinoma
  • Participation in other trials, involving investigational products within 30 days prior to trial entry.
  • Plans to engage in activities which require them to go below 25 feet below sea level.
  • Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00286962

Locations
Netherlands
Isala Klinieken
Zwolle, Netherlands, 8000 GM
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Medtronic
Investigators
Principal Investigator: Henk J Bilo, MD, PhD Isala Clinics, medical research foundation
  More Information

No publications provided by Medical Research Foundation, The Netherlands

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00286962     History of Changes
Other Study ID Numbers: IC-06-01-SL, 04.0211p
Study First Received: February 3, 2006
Last Updated: April 10, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:
Diabetes mellitus, type 1
insulin infusion systems
continuous intraperitoneal insulin infusion
cross-over studies

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014