Status:
COMPLETED
Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus
Lead Sponsor:
Medical Research Foundation, The Netherlands
Collaborating Sponsors:
Medtronic
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 wit...
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 gly...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus
- Intermediate or poor glycemic control, defined as HbA1c ≥ 7,5% AND/OR ≥ 5 incidents of hypoglycemia a week.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00286962
Start Date
February 1 2006
End Date
April 1 2008
Last Update
April 11 2008
Active Locations (1)
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1
Isala Klinieken
Zwolle, Netherlands, 8000 GM