Diabetes Mellitus Type 1NCT00468754
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
A study testing Insulin pumps in people with Diabetes Mellitus Type 1, run by Hoffmann-La Roche at 4 sites in Italy.
Trial summary
This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Insulin pumps
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesItaly
- Study dates
- Jul 2003to May 2005
- Phase
- Interventional
- 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 60 years
- All sexes
- Adult
Who may be able to join
- Type 1 diabetic patients, 18-60 years of age
- Diabetic for >2 years
- Treated with CSII for >=6 months
- HbA1c <8.5%
Who cannot join
- Treatment with daily insulin injections
- Inability to handle pump therapy
- Untreated retinopathy
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Study site
Bergamo, 24128
Study site
Brescia, 25123
Study site
Padova, 35128
Study site
Pisa, 56124
About this study
This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Insulin pumps
- 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.
Insulin pumpsDevice
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: Insulin pumps |
| B | Experimental | Not described Receives: Device: Insulin pumps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variability of blood glucose characterised by the standard deviation of the mean blood glucose
Measured: Length of study
Secondary outcomes (4)
HbA1c
Measured: Length of study
Mean BG during the last month of the respective treatment period
Measured: Length of study
Frequency of severe hypoglycemia
Measured: Length of study
Daily insulin requirement
Measured: Length of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startJul 2003
- Primary completionMay 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Buhr, Study director, Disetronic Medical Systems AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468754
- Sponsor's protocol ID
- RD000275
- Other IDs
- RD000000275
- Status last verified
- Jun 2010
- First submitted
- 2 May 2007
- Last updated
- 3 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
- ClinicalTrials.gov ID
- NCT00468754
- Acronym / sponsor ID
- RD000275
- Conditions
- Diabetes Mellitus Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 3 May 2007 (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.
This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Insulin pumps |
| B | Experimental | Device: Insulin pumps |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Type 1 diabetic patients, 18-60 years of age
- Diabetic for >2 years
- Treated with CSII for >=6 months
- HbA1c <8.5%
Key exclusion criteria (3 listed)
- Treatment with daily insulin injections
- Inability to handle pump therapy
- Untreated 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 |
|---|---|---|
| Insulin pumps | Device | A, B |
Primary outcome
Variability of blood glucose characterised by the standard deviation of the mean blood glucose
Time frame: Length of study
4 secondary outcomes
HbA1c
Time frame: Length of study
Mean BG during the last month of the respective treatment period
Time frame: Length of study
Frequency of severe hypoglycemia
Time frame: Length of study
Daily insulin requirement
Time frame: Length of study
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 3 Mar 2016.
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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.
Andreas Buhr study director
Disetronic Medical Systems AG
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin pumps in people with Diabetes Mellitus Type 1, run by Hoffmann-La Roche at 4 sites in Italy.
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 4 inclusion and 3 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 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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.
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?
Variability of blood glucose characterised by the standard deviation of the mean blood glucose (time frame: Length of study). 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 3 Mar 2016.