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

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

Sponsors

Lead Sponsor: Medical Research Foundation, The Netherlands

Collaborator: Medtronic

Source Medical Research Foundation, The Netherlands
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.

Overall Status Completed
Start Date February 2006
Completion Date April 2008
Primary Completion Date April 2008
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
incidence of hypoglycemia; data taken from patient diaries during either study arm.
Secondary Outcome
Measure Time Frame
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
Condition
Intervention

Intervention Type: Device

Intervention Name: MIP 2007C implantable insulin pump

Description: Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c

Arm Group Label: CIPII

Intervention Type: Device

Intervention Name: continuous subcutaneous insulin infusion (CSII) or MDI

Arm Group Label: CSII/ MDI

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Henk J Bilo, MD, PhD Principal Investigator Isala Clinics, medical research foundation
Location
Facility: Isala Klinieken
Location Countries

Netherlands

Verification Date

April 2008

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CIPII

Type: Experimental

Description: Intraperitoneal insulin infusion by means of an implanted insulin pump

Label: CSII/ MDI

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov