| Trial ID: | L4618 |
| Source ID: | NCT00211536
|
| Associated Drug: |
Medtronic Minimed Implantable Pump Human Recombinant Insulin
|
| Title: |
Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
|
| Acronym: |
MIP310
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00211536/results
|
| Conditions: |
Type 1 Diabetes
|
| Interventions: |
DRUG: Medtronic MiniMed Implantable Pump Human Recombinant Insulin|DEVICE: Medtronic MiniMed Implantable Pump System|DRUG: Aventis HOE21PH U400
|
| Outcome Measures: |
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|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: 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|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|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
|
| Sponsor/Collaborators: |
Sponsor: Medtronic Diabetes
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
107
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-06
|
| Completion Date: |
2008-09
|
| Results First Posted: |
2011-06-23
|
| Last Update Posted: |
2011-09-21
|
| Locations: |
Sansum Medical Research Institute, Santa Barbara, California, 93105, United States|University of Colorado Health Sciences Center, Aurora, Colorado, 80010, United States|Hellman & Rosen Endocrine Associates, North Kansas City, Missouri, 64116, United States|Cleveland Clinic, Wooser, Ohio, 44195, United States|Diabetes & Glandular Disease Clinic, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00211536
|
