Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration

Type 1 Diabetes Clinical Trial

— MIP310  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211536
• Other study ID #: CE-025A6
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: September 19, 2011
• Start date: June 2002
• Est. completion date: September 2008

Study information

• Verified date: August 2011
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: September 2008
• Est. primary completion date: August 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

Drug:
• Medtronic MiniMed Implantable Pump Human Recombinant Insulin
400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Device:
• Medtronic MiniMed Implantable Pump System
The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.

Drug:
• Aventis HOE21PH U400
400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.

Locations

Country	Name	City	State
United States	University of Colorado Health Sciences Center	Aurora	Colorado
United States	Hellman & Rosen Endocrine Associates	North Kansas City	Missouri
United States	Diabetes & Glandular Disease Clinic	San Antonio	Texas
United States	Sansum Medical Research Institute	Santa Barbara	California
United States	Cleveland Clinic	Wooser	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Average Daily Blood Glucose	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.	average from baseline to 12 months	No
Secondary	Mean Amplitude of Glycemic Excursions (MAGE)	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.	average from baseline to 12 months	No
Secondary	Low Blood Glucose Index (LBGI);	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.	average from baseline to 12 months	No