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

April 10, 2008 updated by: Medical Research Foundation, The Netherlands

A Randomized Cross-Over Single Centre Study Comparing the Effects of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zwolle, Netherlands, 8000 GM
        • Isala Klinieken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
incidence of hypoglycemia; data taken from patient diaries during either study arm.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Foundation, The Netherlands

Collaborators

Medtronic

Investigators

  • Principal Investigator: Henk J Bilo, MD, PhD, Isala clinics, medical research foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

February 3, 2006

First Submitted That Met QC Criteria

February 3, 2006

First Posted (Estimate)

February 6, 2006

Study Record Updates

Last Update Posted (Estimate)

April 11, 2008

Last Update Submitted That Met QC Criteria

April 10, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC-06-01-SL
  • 04.0211p

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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