NCT00211536

Brief Summary

The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2002

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

June 23, 2011

Completed
Last Updated

September 21, 2011

Status Verified

August 1, 2011

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Results QC Date

April 25, 2011

Last Update Submit

September 19, 2011

Conditions

Type 1 Diabetes

Keywords

DiabetesImplantable Insulin PumpIntraperitoneal Insulin Delivery

Outcome Measures

Primary Outcomes (2)

  • Change in HbA1c and Compared Between Groups

    To determine whether Intra Peritoneal insulin delivery via MIP results in glycemic control that is equal to or superior (i.e. not inferior to) control with SC therapy (Ho : μ (IP) -μ (SC) ≥ 0.50% A1C), a repeated measures analysis of variance, adjusting for baseline A1C using SAS Proc Mixed was used to compare average A1C trends over time between the two treatment groups (19). Type 3 Least Square (LS) means for each group were assessed. The Estimate statement within SAS proc mixed was used to estimate contrasts among the LS means and confidence intervals for the contrasts.

    Baseline and 12 months

  • Incidence of Severe Hypoglycemia Events

    The total number of severe hypoglycemia events, defined as a clinical episode of hypoglycemia (resulting in seizure or coma, requiring hospitalization, intravenous glucose or glucagon administration), or any hypoglycemia that requires assistance from another person, compared between the two study arms from Baseline to 12 months.

    12 months

Secondary Outcomes (3)

  • Average Daily Blood Glucose

    average from baseline to 12 months

  • Mean Amplitude of Glycemic Excursions (MAGE)

    average from baseline to 12 months

  • Low Blood Glucose Index (LBGI);

    average from baseline to 12 months

Study Arms (2)

MiniMed Implantable insulin Pump (MIP)

EXPERIMENTAL

The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.

Drug: Medtronic MiniMed Implantable Pump Human Recombinant InsulinDevice: Medtronic MiniMed Implantable Pump SystemDrug: Aventis HOE21PH U400

Subcutaneous insulin arm (SC)

NO INTERVENTION

The control group will remain on their current pre-study subcutaneous insulin therapy of either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used, or be required to change or modify their current diabetes therapy for the purpose of the study.

Interventions

Medtronic MiniMed Implantable Pump Human Recombinant InsulinDRUG

400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Also known as: Human insulin injection (rDNA origin)
MiniMed Implantable insulin Pump (MIP)
Medtronic MiniMed Implantable Pump SystemDEVICE

The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.

Also known as: IP insulin pump system
MiniMed Implantable insulin Pump (MIP)
Aventis HOE21PH U400DRUG

400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Also known as: Aventis U400 insulin, Aventis ETP Insulin
MiniMed Implantable insulin Pump (MIP)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • The subject's insulin usage exceeds 66 units per day.
  • Severe complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months
  • Reside at or plan to travel to elevations above 8000 feet during the study period (commercial airline travel is acceptable)
  • Subject who is pregnant, of childbearing potential or lactating and is neither surgically sterile, using contraceptives (devices, oral or implanted) nor other physician approved contraceptive
  • The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data
  • The subject has previously enrolled in or participated in an investigational drug or device study within the preceding 4 weeks
  • The subject has any condition that precludes him/her from completing the study requirements
  • Has plans for activities which require them to go 25 feet below sea level

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Sansum Medical Research Institute

Santa Barbara, California, 93105, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Hellman & Rosen Endocrine Associates

North Kansas City, Missouri, 64116, United States

Location

Cleveland Clinic

Wooser, Ohio, 44195, United States

Location

Diabetes & Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

Insulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
John Shin
Organization
Sr. Clinical Research Manager
john.shin@medtronic.com
818-576-4019

Study Officials

  • Scott W Lee, MD

    Medtronic

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2002

Primary Completion

August 1, 2004

Study Completion

September 1, 2008

Last Updated

September 21, 2011

Results First Posted

June 23, 2011

Record last verified: 2011-08

Locations

US(5)