Trial Outcomes & Findings for Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration (NCT NCT00211536)
NCT ID: NCT00211536
Last Updated: 2011-09-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
107 participants
Primary outcome timeframe
Baseline and 12 months
Results posted on
2011-09-21
Participant Flow
Centers were either university or clinic based endocrinology centers. The centers were required to recruit from their current patient population. This ensured that they had knowledge of the medical and behavioural history prior to enrollment. The experimental pumps were to be implanted and so the study could not be blinded.
All subjects trained on testing for Low Blood Glucose Index (LBGI) and a baseline collection of this data for all subjects was collected prior to a block randomization plan. The randomization visit occured 14 days prior to the study start, to allow for scheduling of the implantation surgery for those randomized to the MIP arm.
Participant milestones
| Measure |
MiniMed Implantable Insulin Pump (MIP)
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.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
Subcutaneous Insulin Arm (SC)
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
54
|
|
Overall Study
As Treated Data Analysis Set
|
52
|
48
|
|
Overall Study
COMPLETED
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
Reasons for withdrawal
| Measure |
MiniMed Implantable Insulin Pump (MIP)
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.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
Subcutaneous Insulin Arm (SC)
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
5
|
|
Overall Study
Adverse Event
|
2
|
0
|
Baseline Characteristics
Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
Baseline characteristics by cohort
| Measure |
MiniMed Implantable Insulin Pump (MIP)
n=52 Participants
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.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
Subcutaneous Insulin Arm (SC)
n=48 Participants
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
43.3 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
40.7 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
42 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
48 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 monthsPopulation: The primary efficacy analysis set is the As treated data set and includes all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values.
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.
Outcome measures
| Measure |
MiniMed Implantable Insulin Pump (MIP)
n=52 Participants
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.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
Subcutaneous Insulin Arm (SC)
n=48 Participants
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
|---|---|---|
|
Change in HbA1c and Compared Between Groups
|
-0.3122449 percent HbA1c
Standard Deviation 0.8908406
|
0.1191489 percent HbA1c
Standard Deviation 0.8691921
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.
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.
Outcome measures
| Measure |
MiniMed Implantable Insulin Pump (MIP)
n=52 Participants
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.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
Subcutaneous Insulin Arm (SC)
n=48 Participants
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
|---|---|---|
|
Incidence of Severe Hypoglycemia Events
|
2 events
|
4 events
|
SECONDARY outcome
Timeframe: average from baseline to 12 monthsPopulation: The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.
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.
Outcome measures
| Measure |
MiniMed Implantable Insulin Pump (MIP)
n=52 Participants
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.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
Subcutaneous Insulin Arm (SC)
n=48 Participants
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
|---|---|---|
|
Average Daily Blood Glucose
|
186.77 mg/dL
Interval 182.7 to 190.83
|
195.8 mg/dL
Interval 192.01 to 199.58
|
SECONDARY outcome
Timeframe: average from baseline to 12 monthsPopulation: The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.
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.
Outcome measures
| Measure |
MiniMed Implantable Insulin Pump (MIP)
n=52 Participants
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.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
Subcutaneous Insulin Arm (SC)
n=48 Participants
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
|---|---|---|
|
Mean Amplitude of Glycemic Excursions (MAGE)
|
136.27 mg/dL
Interval 131.07 to 141.47
|
149.2 mg/dL
Interval 143.09 to 155.31
|
SECONDARY outcome
Timeframe: average from baseline to 12 monthsPopulation: The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set for the purpose of analysis.
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.
Outcome measures
| Measure |
MiniMed Implantable Insulin Pump (MIP)
n=52 Participants
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.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
Subcutaneous Insulin Arm (SC)
n=48 Participants
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group.
The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis.
|
|---|---|---|
|
Low Blood Glucose Index (LBGI);
|
2.14 mg/dL
Interval 1.85 to 2.44
|
2.27 mg/dL
Interval 1.94 to 2.61
|
Adverse Events
MiniMed Implantable Insulin Pump (MIP)
Serious events: 9 serious events
Other events: 51 other events
Deaths: 0 deaths
Subcutaneous Insulin Arm (SC)
Serious events: 7 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MiniMed Implantable Insulin Pump (MIP)
n=53 participants at risk
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.
Results were analyzed for subjects that completed beyond V5, which was the end of the first 90 day period of IP insulin therapy. These were considered to be the "As Treated" group.
All randomized subjects were assessed for safety risk.
|
Subcutaneous Insulin Arm (SC)
n=54 participants at risk
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group. All randomized subjects were assessed for safety risk.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
1/53 • Number of events 1 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
0.00%
0/54 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Infections and infestations
Central Line Infection
|
1.9%
1/53 • Number of events 1 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
0.00%
0/54 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Metabolism and nutrition disorders
Diabetes Mellitus aggravated
|
0.00%
0/53 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
1.9%
1/54 • Number of events 1 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/53 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
1.9%
1/54 • Number of events 1 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
1.9%
1/53 • Number of events 1 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
3.7%
2/54 • Number of events 2 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
3.8%
2/53 • Number of events 2 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
3.7%
2/54 • Number of events 4 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple Myeloma
|
1.9%
1/53 • Number of events 1 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
0.00%
0/54 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Surgical and medical procedures
Operation NOS
|
5.7%
3/53 • Number of events 3 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
0.00%
0/54 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Surgical and medical procedures
Post procedual site infection
|
1.9%
1/53 • Number of events 1 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
0.00%
0/54 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Injury, poisoning and procedural complications
Road traffic Accident
|
0.00%
0/53 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
1.9%
1/54 • Number of events 1 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
3.8%
2/53 • Number of events 2 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
0.00%
0/54 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
Other adverse events
| Measure |
MiniMed Implantable Insulin Pump (MIP)
n=53 participants at risk
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.
Results were analyzed for subjects that completed beyond V5, which was the end of the first 90 day period of IP insulin therapy. These were considered to be the "As Treated" group.
All randomized subjects were assessed for safety risk.
|
Subcutaneous Insulin Arm (SC)
n=54 participants at risk
The control group will remain on their pre-study subcutaneous insulin therapy 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.
For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the "As Treated" group. All randomized subjects were assessed for safety risk.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia NOS
|
20.8%
11/53 • Number of events 13 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
7.4%
4/54 • Number of events 4 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Metabolism and nutrition disorders
Hypoglycemia NOS
|
24.5%
13/53 • Number of events 23 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
1.9%
1/54 • Number of events 2 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Infections and infestations
Nasopharygitis
|
17.0%
9/53 • Number of events 12 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
11.1%
6/54 • Number of events 8 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Immune system disorders
Seasonal allergy
|
9.4%
5/53 • Number of events 8 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
3.7%
2/54 • Number of events 2 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Infections and infestations
Upper respiratory tract infection NOS
|
20.8%
11/53 • Number of events 14 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
14.8%
8/54 • Number of events 9 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
|
Renal and urinary disorders
Urinary tract infection
|
9.4%
5/53 • Number of events 5 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
11.1%
6/54 • Number of events 7 • Adverse event data collected from screening at 30 days prior to randomization until end of study phase at one year.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60