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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
MIP 2007C implantable insulin pump
continuous subcutaneous insulin infusion (CSII) or MDI
Sponsored by
Medical Research Foundation, The Netherlands
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes mellitus, type 1, insulin infusion systems, continuous intraperitoneal insulin infusion, cross-over studies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Isala Klinieken

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CIPII

CSII/ MDI

Arm Description

Intraperitoneal insulin infusion by means of an implanted insulin pump

Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII) or by multiple daily injections (MDI)

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
February 3, 2006
Last Updated
April 10, 2008
Sponsor
Medical Research Foundation, The Netherlands
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT00286962
Brief Title
Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical Research Foundation, The Netherlands
Collaborators
Medtronic

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes mellitus, type 1, insulin infusion systems, continuous intraperitoneal insulin infusion, cross-over studies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CIPII
Arm Type
Experimental
Arm Description
Intraperitoneal insulin infusion by means of an implanted insulin pump
Arm Title
CSII/ MDI
Arm Type
Active Comparator
Arm Description
Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII) or by multiple daily injections (MDI)
Intervention Type
Device
Intervention Name(s)
MIP 2007C implantable insulin pump
Intervention Description
Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c
Intervention Type
Device
Intervention Name(s)
continuous subcutaneous insulin infusion (CSII) or MDI
Primary Outcome Measure Information:
Title
incidence of hypoglycemia; data taken from patient diaries during either study arm.
Secondary Outcome Measure Information:
Title
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.
Title
average daily insulin usage; as taken from patient diaries for both study arms
Title
frequency of adverse events; as taken from patient diaries for both study arms
Title
frequency of clinically significant abnormal laboratory values and device complications; as taken from patient diaries for both study arms
Title
Quality of life; score on a quality of life scale at baseline and end of either study arm
Title
Treatment satisfaction; score on treatment satisfaction scale at baseline and end of either study arm
Title
daily glucose excursions; measured with continuous glucose monitoring system (CGMS) at baseline, halfway through and at the end of both study arms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henk J Bilo, MD, PhD
Organizational Affiliation
Isala Clinics, medical research foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8000 GM
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
20185731
Citation
Logtenberg SJ, Kleefstra N, Houweling ST, Groenier KH, Gans RO, Bilo HJ. Health-related quality of life, treatment satisfaction, and costs associated with intraperitoneal versus subcutaneous insulin administration in type 1 diabetes: a randomized controlled trial. Diabetes Care. 2010 Jun;33(6):1169-72. doi: 10.2337/dc09-1758. Epub 2010 Feb 25.
Results Reference
derived

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

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