Diabetes Mellitus, Type 1Phase 3NCT00286962
Study to Compare Intraperitoneal Insulin to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus
A Phase 3 study testing MIP 2007C implantable insulin pump and continuous subcutaneous insulin infusion (CSII) or MDI in people with Diabetes Mellitus, Type 1, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous administration of insulin regarding safety, glycemic control and number of episodes of hypoglycemia in patients with type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- MIP 2007C implantable insulin pump and continuous subcutaneous insulin infusion (CSII) or MDI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2006to Apr 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus
- Intermediate or poor glycemic control, defined as HbA1c ≥ 7,5% AND/OR ≥ 5 incidents of hypoglycemia a week.
Who cannot join
- renal function impairment: creatinin ≥ 150 micromol/L or a creatinin clearance < 50 ml/min
- Cardiac problems: decompensated heart failure (NYHA III and IV); diagnosis of unstable angina pectoris; myocardial infarction within the last 12 months
- Known or suspected allergy against insulin or any component of the composition
- Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past.
- Severe untreated proliferative retinopathy.
- Insufficient knowledge of the Dutch language to understand the requirements of the study.
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- Current use of systemic corticosteroids or suffering from a condition which caused systemic corticosteroid use more than once in the last year.
- Substance abuse, other than nicotine
- A history of cancer, excluding well differentiated thyroid carcinoma, breast carcinoma without lymph node metastases and skin carcinoma
- Participation in other trials, involving investigational products within 30 days prior to trial entry.
- Plans to engage in activities which require them to go below 25 feet below sea level.
- Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Cross-Over Single Centre Study Comparing the Effects of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus Patients
The purpose of this study is to compare intraperitoneal (IP) therapy to subcutaneous administration of insulin regarding safety, glycemic control and number of episodes of hypoglycemia in patients with type 1 diabetes mellitus.
Read the detailed description
Various study data available suggest that intraperitoneal (IP) delivery of insulin in type 1 and type 2 diabetic subjects provides an appropriate therapy that allows subjects to achieve acceptable glycemic control without increasing the inherent risk of severe hypoglycemia observed when intensive insulin treatment is pursued. Up till now little research has been done to investigate the efficacy of intraperitoneal (IP) therapy compared to subcutaneous administration. In this study we aim for safety and non-inferiority or superiority for IP therapy concerning glycemic control with less episodes of hypoglycemia compared to intensive subcutaneous (SC) therapy in intermediate or poorly controlled Type 1 patients and/or patients with frequent severe hypoglycemic events.
Subjects will be randomized to insulin treatment using the Medtronic Minimed Implantable Pump or to subcutaneous insulin therapy during the first study arm. After the first arm of the study, subjects will be crossed over to the second arm and will receive the treatment whichever they had not received in the first treatment phase. Subjects with the MIP already implanted will retain the pump but will receive diluent intraperitoneally for the second study arm.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- MIP 2007C implantable insulin pump, continuous subcutaneous insulin infusion (CSII) or MDI
- Keywords
- Diabetes mellitus, type 1, insulin infusion systems, continuous intraperitoneal insulin infusion, cross-over studies
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIP 2007C implantable insulin pumpDevice
Intraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c
continuous subcutaneous insulin infusion (CSII) or MDIDevice
| Study group | Role | What they receive |
|---|---|---|
| CIPII | Experimental | Intraperitoneal insulin infusion by means of an implanted insulin pump Receives: Device: MIP 2007C implantable insulin pump |
| CSII/ MDI | Active comparator | Optimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII) or by multiple daily injections (MDI) Receives: Device: continuous subcutaneous insulin infusion (CSII) or MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of hypoglycemia; data taken from patient diaries during either study arm.
Secondary outcomes (7)
glycemic control; glycosylated hemoglobin (HbA1c) measurement at baseline, end of entry phase, start of both study arms, halfway through study arms, end of study arms.
average daily insulin usage; as taken from patient diaries for both study arms
frequency of adverse events; as taken from patient diaries for both study arms
frequency of clinically significant abnormal laboratory values and device complications; as taken from patient diaries for both study arms
Quality of life; score on a quality of life scale at baseline and end of either study arm
Treatment satisfaction; score on treatment satisfaction scale at baseline and end of either study arm
daily glucose excursions; measured with continuous glucose monitoring system (CGMS) at baseline, halfway through and at the end of both study arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Research Foundation, The Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Investigators
- Henk J Bilo, MD, PhD, Principal investigator, Isala Clinics, medical research foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286962
- Sponsor's protocol ID
- IC-06-01-SL
- Other IDs
- 04.0211p
- Status last verified
- Apr 2008
- First submitted
- 3 Feb 2006
- Last updated
- 11 Apr 2008
- Results posted
- No
Publications
Logtenberg SJ, Kleefstra N, Houweling ST, Groenier KH, Gans RO, Bilo HJ. Health-related quality of life, treatment satisfaction, and costs associated with intraperitoneal versus subcutaneous insulin administration in type 1 diabetes: a randomized controlled trial. Diabetes Care. 2010 Jun;33(6):1169-72. doi: 10.2337/dc09-1758. Epub 2010 Feb 25.
PubMed 20185731
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cross-Over Single Centre Study Comparing the Effects of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration in Type 1 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT00286962
- Acronym / sponsor ID
- IC-06-01-SL
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes mellitus, type 1, insulin infusion systems, continuous intraperitoneal insulin infusion, cross-over studies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Medical Research Foundation, The NetherlandsUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Feb 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 6 Feb 2006 (estimated)
- Results
- Not posted in the source record
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 compare intraperitoneal (IP) therapy to subcutaneous administration of insulin regarding safety, glycemic control and number of episodes of hypoglycemia in patients with type 1 diabetes mellitus.
Detailed description
Various study data available suggest that intraperitoneal (IP) delivery of insulin in type 1 and type 2 diabetic subjects provides an appropriate therapy that allows subjects to achieve acceptable glycemic control without increasing the inherent risk of severe hypoglycemia observed when intensive insulin treatment is pursued. Up till now little research has been done to investigate the efficacy of intraperitoneal (IP) therapy compared to subcutaneous administration. In this study we aim for safety and non-inferiority or superiority for IP therapy concerning glycemic control with less episodes of hypoglycemia compared to intensive subcutaneous (SC) therapy in intermediate or poorly controlled Type 1 patients and/or patients with frequent severe hypoglycemic events.
Subjects will be randomized to insulin treatment using the Medtronic Minimed Implantable Pump or to subcutaneous insulin therapy during the first study arm. After the first arm of the study, subjects will be crossed over to the second arm and will receive the treatment whichever they had not received in the first treatment phase. Subjects with the MIP already implanted will retain the pump but will receive diluent intraperitoneally for the second study arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIPII | Experimental | Device: MIP 2007C implantable insulin pumpIntraperitoneal insulin infusion by means of an implanted insulin pump |
| CSII/ MDI | Active comparator | Device: continuous subcutaneous insulin infusion (CSII) or MDIOptimized subcutaneous insulin infusion by means of continuous subcutaneous insulin infusion (CSII) or by multiple daily injections (MDI) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 diabetes mellitus
- Intermediate or poor glycemic control, defined as HbA1c ≥ 7,5% AND/OR ≥ 5 incidents of hypoglycemia a week.
Key exclusion criteria (12 listed)
- renal function impairment: creatinin ≥ 150 micromol/L or a creatinin clearance < 50 ml/min
- Cardiac problems: decompensated heart failure (NYHA III and IV); diagnosis of unstable angina pectoris; myocardial infarction within the last 12 months
- Known or suspected allergy against insulin or any component of the composition
- Mental retardation or psychiatric treatment for schizophrenia, organic mental disorder or bipolar disorder currently or in the past.
- Severe untreated proliferative retinopathy.
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 |
|---|---|---|
| MIP 2007C implantable insulin pumpIntraperitoneal insulin infusion delivered by an implantable pump: MIP 2007c | Device | CIPII |
| continuous subcutaneous insulin infusion (CSII) or MDI | Device | CSII/ MDI |
Primary outcome
incidence of hypoglycemia; data taken from patient diaries during either study arm.
7 secondary outcomes
glycemic control; glycosylated hemoglobin (HbA1c) measurement at baseline, end of entry phase, start of both study arms, halfway through study arms, end of study arms.
average daily insulin usage; as taken from patient diaries for both study arms
frequency of adverse events; as taken from patient diaries for both study arms
frequency of clinically significant abnormal laboratory values and device complications; as taken from patient diaries for both study arms
Quality of life; score on a quality of life scale at baseline and end of either study arm
Treatment satisfaction; score on treatment satisfaction scale at baseline and end of either study arm
daily glucose excursions; measured with continuous glucose monitoring system (CGMS) at baseline, halfway through and at the end of both study arms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2008.
- Derived from this study: PubMed 20185731Logtenberg SJ, Kleefstra N, Houweling ST, Groenier KH, Gans RO, Bilo HJ. Health-related quality of life, treatment satisfaction, and costs associated with intraperitoneal versus subcutaneous insulin administration in type 1 diabetes: a randomized controlled trial. Diabetes Care. 2010 Jun;33(6):1169-72. doi: 10.2337/dc09-1758. Epub 2010 Feb 25.
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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.
Henk J Bilo, MD, PhD principal investigator
Isala Clinics, medical research foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MIP 2007C implantable insulin pump and continuous subcutaneous insulin infusion (CSII) or MDI in people with Diabetes Mellitus, Type 1, run by Medical Research Foundation, The Netherlands at 1 site in Netherlands.
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 2 inclusion and 12 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 11 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of hypoglycemia; data taken from patient diaries during either study arm.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00286962, which also lists 1 linked publication.
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 11 Apr 2008.