TReatment by Insulin Continuous Infusion in Type 2 DIAbetes

NCT ID: NCT01889914

Last Updated: 2013-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2015-09-30

Brief 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 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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

continuous infusion of insulin by pump

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)

Group Type: EXPERIMENTAL

2 different procedures of administration of insulin

Intervention Type: DRUG

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

discontinuous insulin multiple injections

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

Group Type: EXPERIMENTAL

2 different procedures of administration of insulin

Intervention Type: DRUG

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

Interventions

2 different procedures of administration of insulin

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

Intervention Type: DRUG

Other Intervention Names

multiple daily discontinuous injections of insulin; continuous infusion of rapid insulin by an external pump

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• Practices of violent sports
• Professional extreme environment of cold or heat
• Serious psychiatric diseases physical and/or psychiatric Incapacitated medically significant
• Poor sanitation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sabine RUDONI, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de BOCAGE, DIJON, FRANCE

Locations

CHU

Dijon, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Sabine RUDONI, MD

Role: primary

sabine.rudoni@chu-dijon.fr

Other Identifiers

2011-004602-19

Identifier Type: -

Identifier Source: org_study_id