TReatment by Insulin Continuous Infusion in Type 2 DIAbetes (TRICIDIA2)

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Drug: 2 different procedures of administration 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Recruiting
    • CHU
    • Contact: Sabine RUDONI, MD; Email: sabine.rudoni@chu-dijon.fr
    • Principal Investigator: Sabine RUDONI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	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; Other Names: multiple daily discontinuous injections of insulin; continuous infusion of rapid insulin by an external pump
Experimental: 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	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; Other Names: multiple daily discontinuous injections of insulin; continuous infusion of rapid insulin by an external pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
change from baseline in quality of life measured with questionnaires at 6 months	baseline and 6 months
change from baseline in weight at three, six, nine and twelve months in the two groups.	baseline and three, six, nine and twelve months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon
• Investigators: Principal Investigator: Sabine RUDONI, MD, CHU de BOCAGE, DIJON, FRANCE

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): September 1, 2015

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 28, 2013
• First Posted (Estimate): July 1, 2013

Study Record Updates

• Last Update Posted (Estimate): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 28, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 2011-004602-19