Skip to main content
OpenTrials
Completed

NCT Number: NCT00211536

Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sansum Medical Research Institute, Santa Barbara, California, United States

Loading trial locations.

About this study

Implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in Type 1 DM subjects, as demonstrated in numerous European studies. Glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia. This study is aimed at comparing the efficacy of intraperitoneal (IP) insulin therapy to intensive subcutaneous insulin therapy over a period of 12 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Type 1 diabetes mellitus (American Diabetes Association definition)
  • HbA1c greater than or equal to 7.5%
  • Intensive insulin treatment for at least 3 months
  • Physical and intellectual ability to operate MIP system
  • Subject has been under the routine care of the investigator for at least two months prior to enrollment
  • Subject has a reliable support person (defined as a person who has daily contact with the subject and knows whom to contact in the event of an emergency).
  • Capability and willingness to perform self-monitoring of blood glucose at least four times daily for 9 months of the study and 7 times daily for 3 months of the study
  • Physical and intellectual ability to operate the MIP system and to comply with the data reporting requirements of the study.
  • Subject is willing to sign the informed consent form (approved by local Institutional Review Board and Medtronic MiniMed)

Exclusion criteria

  • 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

Treatment and study plan

Medtronic MiniMed Implantable Pump Human Recombinant Insulin

Drug

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

Other names: Human insulin injection (rDNA origin)

Medtronic MiniMed Implantable Pump System

Device

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

Other names: IP insulin pump system

Aventis HOE21PH U400

Drug

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

Other names: Aventis U400 insulin, Aventis ETP Insulin

Primary outcomes

  1. Change in HbA1c and Compared Between Groups

    Time frame: Baseline and 12 months

    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.

  2. Incidence of Severe Hypoglycemia Events

    Time frame: 12 months

    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.

Secondary outcomes

  1. Average Daily Blood Glucose

    Time frame: average from baseline to 12 months

    For each subject, a minimum of two blood glucose readings per day was required for calculation of the average daily mean. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.

  2. Mean Amplitude of Glycemic Excursions (MAGE)

    Time frame: average from baseline to 12 months

    MAGE was calculated by taking the arithmetic mean of BG excursions when both ascending and descending segments of the curve exceed one Standard Deviation of the average 24-hour BG value. MAGE was calculated for each subject using SMBG data from periods in which subjects had a minimum of 4 and maximum of 10 readings daily. The overall mean of the mean for each subject for the measure time frame was then calculated. The mean of the results for all subjects in each group were then analyzed and compared between groups both at Baseline and 12 months.

  3. Low Blood Glucose Index (LBGI);

    Time frame: average from baseline to 12 months

    4 to 10 daily blood glucose readings (BG) were required for this measure. LBGI was calculated from BG values collected for 30 days prior to Visit 2 and 30 days following Visits 5 and 7. The continuous measure was compared between the two treatment groups for the three periods with a repeated measures ANOVA using proc mixed. Type 3 least square means for each group were assessed and estimate statements used to make comparisons among the LS means and create confidence intervals on the contrasts.

Sponsors and collaborators

Lead sponsor

Medtronic MiniMed, Inc.

Industry

Registry information

Official study title

A Randomized, Active Control, Multi-Center Study Comparing the Effect of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration on Glycemic Control and the Frequency of Severe Hypoglycemia

Acronym: MIP310

Important dates

Study start
2002
Primary completion
2004
Study completion
2008
First posted
Sep 21, 2005
Registry last updated
Sep 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.