TReatment by Insulin Continuous Infusion in Type 2 DIAbetes

NCT01889914 | Unknown Phase 4

• 1 other identifier: 2011-004602-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

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)

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

Drug: 2 different procedures of administration of insulin

Interventions

2 different procedures of administration of insulin 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

Also known as: multiple daily discontinuous injections of insulin, continuous infusion of rapid insulin by an external pump

continuous infusion of insulin by pump; discontinuous insulin multiple injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sabine RUDONI, MD

  CHU de BOCAGE, DIJON, FRANCE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: July 1, 2013
• Study Start: January 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: September 1, 2015
• Last Updated: July 1, 2013

Record last verified: 2013-06

Locations

FR (1)