Type 1 DiabetesPhase 3MIP310NCT00211536
Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration
A Phase 3 study testing Medtronic MiniMed Implantable Pump Human Recombinant Insulin, Medtronic MiniMed Implantable Pump System and Aventis HOE21PH U400 in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Medtronic MiniMed Implantable Pump Human Recombinant Insulin, Medtronic MiniMed Implantable Pump System and Aventis HOE21PH U400
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2002to Sep 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado Health Sciences Center
Aurora, Colorado, 80010
Hellman & Rosen Endocrine Associates
North Kansas City, Missouri, 64116
Diabetes & Glandular Disease Clinic
San Antonio, Texas, 78229
Sansum Medical Research Institute
Santa Barbara, California, 93105
Cleveland Clinic
Wooser, Ohio, 44195
About this study
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
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.
Read the detailed 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Medtronic MiniMed Implantable Pump Human Recombinant Insulin, Medtronic MiniMed Implantable Pump System, Aventis HOE21PH U400
- Keywords
- Diabetes, Implantable Insulin Pump, Intraperitoneal Insulin Delivery
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic MiniMed Implantable Pump Human Recombinant InsulinDrug
Also called Human insulin injection (rDNA origin)
400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.
Medtronic MiniMed Implantable Pump SystemDevice
Also called IP insulin pump system
The implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes.
Aventis HOE21PH U400Drug
Also called Aventis U400 insulin, Aventis ETP Insulin
400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Medtronic MiniMed Implantable Pump Human Recombinant Insulin; Device: Medtronic MiniMed Implantable Pump System; Drug: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: average from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2002
- Primary completionAug 2004
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott W Lee, MD, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211536
- Sponsor's protocol ID
- CE-025A6
- Acronym
- MIP310
- Status last verified
- Aug 2011
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00211536
- Acronym / sponsor ID
- MIP310 / CE-025A6
- Conditions
- Type 1 Diabetes
- Keywords
- Diabetes, Implantable Insulin Pump, Intraperitoneal Insulin Delivery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2002
- Primary completion
- Aug 2004 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 23 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MiniMed Implantable insulin Pump (MIP) | Experimental | Drug: Medtronic MiniMed Implantable Pump Human Recombinant Insulin, Device: Medtronic MiniMed Implantable Pump System, Drug: Aventis HOE21PH U400The 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic MiniMed Implantable Pump Human Recombinant InsulinAlso: Human insulin injection (rDNA origin)400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements. | Drug | MiniMed Implantable insulin Pump (MIP) |
| Medtronic MiniMed Implantable Pump SystemAlso: IP insulin pump systemThe implantable pump system is intended to provide continuous intraperitoneal delivery of insulin in subjects with diabetes. | Device | MiniMed Implantable insulin Pump (MIP) |
| Aventis HOE21PH U400Also: Aventis U400 insulin, Aventis ETP Insulin400 IU per ml - dosage based on the Investigators clinical judgement and the individual subject requirements. | Drug | MiniMed Implantable insulin Pump (MIP) |
Primary outcome
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.
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.
3 secondary outcomes
Average Daily Blood Glucose
Time frame: average from baseline to 12 months
Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: average from baseline to 12 months
Low Blood Glucose Index (LBGI);
Time frame: average from baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott W Lee, MD study director
Medtronic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Medtronic MiniMed Implantable Pump Human Recombinant Insulin, Medtronic MiniMed Implantable Pump System and Aventis HOE21PH U400 in people with Type 1 Diabetes, run by Medtronic MiniMed, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c and Compared Between Groups (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2011.