DiabetesPhase 4TRICIDIA2NCT01889914
TReatment by Insulin Continuous Infusion in Type 2 DIAbetes
A Phase 4 study testing 2 different procedures of administration of insulin in people with Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
The aim of the TRICIDIA2 study is to compare two modalities of administration of insulin. In our future study, the investigators wish to study if the treatment by continuous infusion of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators indeed expect that the insulin delivered in a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- 2 different procedures of administration of insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Sep 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years old
- type 2 diabete patient with insuline basal/bolus treatment for at least 6 months
- Doses of insuline > 0,7 U/Kg/j
- HbA1c ≥ 7,5%
- without ADO for at least 4 weeks (sulfamides, Incrétines, glinides, acarbose) except the metformine
- BMI ≥ 28,5 kg/m²
- clinical diagnostique of diabetes for at least 10 ans
- Patient must be able to Realize an automonitoring and to manage the functioning of an insulin pump.
Who cannot join
- glitazone treatment less than 3 month before inclusion
- Patient with an untreated by the laser proliferative ischemic retinopathy
- BMI < 28,5 kg/m²
- Pacemaker (CI IRM)
- Presence of implantable material (CI IRM)
- Pregnancy, breast-feeding
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- Practices of violent sports
- Professional extreme environment of cold or heat
- Serious psychiatric diseases physical and/or psychiatric Incapacitated medically significant
- Poor sanitation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU
Dijon, 21000
Sabine RUDONI, MD, sabine.rudoni@chu-dijon.fr
Sabine RUDONI, MD
About this study
Official title: Treatment by Subcutaneous Continuous Infusion of Insulin by Portable Pump Versus Discontinuous Infusion of Insulin by Multi-injections in the Type 2 Diabetes: Study of the Insulinosensibility in the 2 Types of Treatments
The aim of the TRICIDIA2 study is to compare two modalities of administration of insulin.
In our future study, the investigators wish to study if the treatment by continuous infusion of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators indeed expect that the insulin delivered in a continuous way decreases the insulino-resistance of these patients compared with the intermittent delivering of insulin.
Read the detailed description
We wish to use before and after treatment the classic tools of measure of insulinosensitivity / the euglycemic hyperinsulinemic clamp associated with a measure of the insulinosecretion thanks to a test of load in glucose IV. The coupling in the same procedure of these 2 tests is the Botnia clamp. We also wish to use the continuous measure of subcutaneous glucose during several days to estimate the reduction in the average glycemia on the fast and prandial periods as well as the decrease of the time spent in hyperglycemia during the day. This tool demonstrated its interest in type 2 diabetic population in several studies. Finally the current / spectro-IRM methods of imaging are now validated to quantify and measure exactly the importance of the steatosis, including in type 2 patients, because we know that it is probably the result of the insulino-resistance; We would also like to demonstrate that some genetic polymorphisms of proteins (polymorphisms G / T493 of the MTP, 1927 C/T of the receiver R1 of the adiponectin and 265 C/T of the gene of Apolipoprotéines A) are factors which can modulate the steatosis development in case of type 2 diabetes.
In other secondary criteria we wait for an improvement of HbA1c, quality of life of type 2 obese people with regard to the treatment by intensified Multi-injections.
- Conditions
- Diabetes
- Being tested
- 2 different procedures of administration of insulin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 different procedures of administration of insulinDrug
Also called multiple daily discontinuous injections of insulin, continuous infusion of rapid insulin by an external pump
Compare the efficiency of both types of therapeutic care in insulinoresistant type 2 diabetic patients: insulin multi injections (levemir et Apidra versus continuous infusion of insulin apidra by pump
| Study group | Role | What they receive |
|---|---|---|
| continuous infusion of insulin by pump | Experimental | in this arm called "continuous infusion of insulin with a pump" the patient receive continuous rapid insulin (APIDRA ®)with an external pump.
An hepatic IRM and a botnia test will be practice before and six months after the beginning of this treatment(continuous insulin) Receives: Drug: 2 different procedures of administration of insulin |
| discontinuous insulin multiple injections | Experimental | An arm called " intensification of the multiple daily injections ": the patient will receive an additional injection of basal insulin LEVEMIR® : five injections per day (2 injections of Levemir® and 3 injections of Apidra®) instead of four previously (1 injection of Levemir® and 3 injections of Apidra®).
An hepatic IRM and a botnia test will be practice before and six months after the beginning of the treatment Receives: Drug: 2 different procedures of administration of insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes from baseline in insulinoresistance measured by biological tests of hyperinsulinemic euglycemic clamp in the two groups of treatment 6 months after the start of the treatment.
Measured: baseline and six months after the begining of the study
Secondary outcomes (4)
change from baseline in the hyperglycemia time spent during basal and prandial period with continuous glucose monitoring tool at 6 months
Measured: baseline and six months after the beginning of the study
change from baseline in HbA1c in the two groups of treatment at three, six, nine and twelve months
Measured: baseline and three, six, nine, twelve months
change from baseline in quality of life measured with questionnaires at 6 months
Measured: baseline and 6 months
change from baseline in weight at three, six, nine and twelve months in the two groups.
Measured: baseline and three, six, nine and twelve months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2013 (estimated)
- Study startJan 2012
- Primary completionMar 2015 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine RUDONI, MD, Principal investigator, CHU de BOCAGE, DIJON, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889914
- Sponsor's protocol ID
- 2011-004602-19
- Acronym
- TRICIDIA2
- Status last verified
- Jun 2013
- First submitted
- 6 Jun 2013
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment by Subcutaneous Continuous Infusion of Insulin by Portable Pump Versus Discontinuous Infusion of Insulin by Multi-injections in the Type 2 Diabetes: Study of the Insulinosensibility in the 2 Types of Treatments
- ClinicalTrials.gov ID
- NCT01889914
- Acronym / sponsor ID
- TRICIDIA2 / 2011-004602-19
- Conditions
- Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 1 Jul 2013 (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 aim of the TRICIDIA2 study is to compare two modalities of administration of insulin.
In our future study, the investigators wish to study if the treatment by continuous infusion of insulin improves the insulinosensitivity of type 2 diabetic patients; the investigators indeed expect that the insulin delivered in a continuous way decreases the insulino-resistance of these patients compared with the intermittent delivering of insulin.
Detailed description
We wish to use before and after treatment the classic tools of measure of insulinosensitivity / the euglycemic hyperinsulinemic clamp associated with a measure of the insulinosecretion thanks to a test of load in glucose IV. The coupling in the same procedure of these 2 tests is the Botnia clamp. We also wish to use the continuous measure of subcutaneous glucose during several days to estimate the reduction in the average glycemia on the fast and prandial periods as well as the decrease of the time spent in hyperglycemia during the day. This tool demonstrated its interest in type 2 diabetic population in several studies. Finally the current / spectro-IRM methods of imaging are now validated to quantify and measure exactly the importance of the steatosis, including in type 2 patients, because we know that it is probably the result of the insulino-resistance; We would also like to demonstrate that some genetic polymorphisms of proteins (polymorphisms G / T493 of the MTP, 1927 C/T of the receiver R1 of the adiponectin and 265 C/T of the gene of Apolipoprotéines A) are factors which can modulate the steatosis development in case of type 2 diabetes.
In other secondary criteria we wait for an improvement of HbA1c, quality of life of type 2 obese people with regard to the treatment by intensified Multi-injections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous infusion of insulin by pump | Experimental | Drug: 2 different procedures of administration of insulinin this arm called "continuous infusion of insulin with a pump" the patient receive continuous rapid insulin (APIDRA ®)with an external pump. An hepatic IRM and a botnia test will be practice before and six months after the beginning of this treatment(continuous insulin) |
| discontinuous insulin multiple injections | Experimental | Drug: 2 different procedures of administration of insulinAn arm called " intensification of the multiple daily injections ": the patient will receive an additional injection of basal insulin LEVEMIR® : five injections per day (2 injections of Levemir® and 3 injections of Apidra®) instead of four previously (1 injection of Levemir® and 3 injections of Apidra®). An hepatic IRM and a botnia test will be practice before and six months after the beginning of the treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age > 18 years old
- type 2 diabete patient with insuline basal/bolus treatment for at least 6 months
- Doses of insuline > 0,7 U/Kg/j
- HbA1c ≥ 7,5%
- without ADO for at least 4 weeks (sulfamides, Incrétines, glinides, acarbose) except the metformine
Key exclusion criteria (10 listed)
- glitazone treatment less than 3 month before inclusion
- Patient with an untreated by the laser proliferative ischemic retinopathy
- BMI < 28,5 kg/m²
- Pacemaker (CI IRM)
- Presence of implantable material (CI IRM)
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 |
|---|---|---|
| 2 different procedures of administration of insulinAlso: multiple daily discontinuous injections of insulin, continuous infusion of rapid insulin by an external pumpCompare the efficiency of both types of therapeutic care in insulinoresistant type 2 diabetic patients: insulin multi injections (levemir et Apidra versus continuous infusion of insulin apidra by pump | Drug | continuous infusion of insulin by pump, discontinuous insulin multiple injections |
Primary outcome
changes from baseline in insulinoresistance measured by biological tests of hyperinsulinemic euglycemic clamp in the two groups of treatment 6 months after the start of the treatment.
Time frame: baseline and six months after the begining of the study
4 secondary outcomes
change from baseline in the hyperglycemia time spent during basal and prandial period with continuous glucose monitoring tool at 6 months
Time frame: baseline and six months after the beginning of the study
change from baseline in HbA1c in the two groups of treatment at three, six, nine and twelve months
Time frame: baseline and three, six, nine, twelve months
change from baseline in quality of life measured with questionnaires at 6 months
Time frame: baseline and 6 months
change from baseline in weight at three, six, nine and twelve months in the two groups.
Time frame: baseline and three, six, nine and twelve months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
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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.
Sabine RUDONI, MD principal investigator
CHU de BOCAGE, DIJON, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2 different procedures of administration of insulin in people with Diabetes, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Jul 2013. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes from baseline in insulinoresistance measured by biological tests of hyperinsulinemic euglycemic clamp in the two groups of treatment 6 months after the start of the treatment. (time frame: baseline and six months after the begining of the 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 1 Jul 2013.