TReatment by Insulin Continuous Infusion in Type 2 DIAbetes

Diabetes Clinical Trial

— TRICIDIA2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01889914
• Other study ID #: 2011-004602-19
• Status: Recruiting
• Phase: Phase 4
• First received: June 6, 2013
• Last updated: June 28, 2013
• Start date: January 2012
• Est. completion date: September 2015

Study information

• Verified date: June 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical 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 continuous way decreases the insulino-resistance of these patients compared with the intermittent delivering of insulin.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	CHU	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		baseline and six months after the begining of the study	Yes
Secondary	change from baseline in the hyperglycemia time spent during basal and prandial period with continuous glucose monitoring tool at 6 months		baseline and six months after the beginning of the study	Yes
Secondary	change from baseline in HbA1c in the two groups of treatment at three, six, nine and twelve months		baseline and three, six, nine, twelve months	Yes
Secondary	change from baseline in quality of life measured with questionnaires at 6 months		baseline and 6 months	Yes
Secondary	change from baseline in weight at three, six, nine and twelve months in the two groups.		baseline and three, six, nine and twelve months	Yes