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

NCT ID: NCT00286962

Last Updated: 2008-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-04-30

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes mellitus, type 1; insulin infusion systems; continuous intraperitoneal insulin infusion; cross-over studies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CIPII

Intraperitoneal insulin infusion by means of an implanted insulin pump

Group Type: EXPERIMENTAL

MIP 2007C implantable insulin pump

Intervention Type: DEVICE

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

CSII/ MDI

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

Group Type: ACTIVE_COMPARATOR

continuous subcutaneous insulin infusion (CSII) or MDI

Intervention Type: DEVICE

Interventions

MIP 2007C implantable insulin pump

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

Intervention Type: DEVICE

continuous subcutaneous insulin infusion (CSII) or MDI

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medical Research Foundation, The Netherlands

OTHER

Sponsor Role: lead

Principal Investigators

Henk J Bilo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Isala Clinics, medical research foundation

Locations

Isala Klinieken

Zwolle, , Netherlands

Countries

Netherlands

References

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.

Reference Type: DERIVED

PMID: 20185731 (View on PubMed)

Other Identifiers

04.0211p

Identifier Type: -

Identifier Source: secondary_id

IC-06-01-SL

Identifier Type: -

Identifier Source: org_study_id