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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Centre Hospitalier Universitaire Dijon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01889914
First received: June 6, 2013
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Diabetes
Drug: 2 different procedures of administration of insulin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • change from baseline in quality of life measured with questionnaires at 6 months [ Time Frame: baseline and 6 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01889914

Locations
France
CHU Recruiting
Dijon, France, 21000
Contact: Sabine RUDONI, MD       sabine.rudoni@chu-dijon.fr   
Principal Investigator: Sabine RUDONI, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Investigators
Principal Investigator: Sabine RUDONI, MD CHU de BOCAGE, DIJON, FRANCE
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01889914     History of Changes
Other Study ID Numbers: 2011-004602-19
Study First Received: June 6, 2013
Last Updated: June 28, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014