Back to resultsTreatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes (TRICIDIA)
Primary Purpose
Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy
Status
Unknown status
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
LEVEMIR
APIDRA
Sponsored by
About this trial
This is an interventional treatment trial for Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy
Eligibility Criteria
Inclusion Criteria:
- Persons who have provided written informed consent
- Age > 18 years
- Patients with type 2 diabetes treated with insulin using a basal / bolus strategy for at least 6 months
- Doses of insulin > 0.7 U / Kg / d
- HbA1c ≥ 7.5 %
- Without OAD for at least 4 weeks (sulfamides, Incretines, glinides, acarbose) except Metformin
- BMI ≥ 28.5 kg / m2
- Diabetes diagnosed for at least 10 years
- Patients able to monitor themselves and manage an insulin pump.
Exclusion Criteria:
- Patients treated with glitazones during the 3 months preceding inclusion
- Patients with proliferative ischemic retinopathy not treated by laser
- BMI < 28.5 kg / m2
- Presence of implantable material ( CI MRI )
- Pacemaker ( CI MRI )
- Pregnancy, breast feeding
- Medically significant physical or psychiatric inability, patients under guardianship or wards of court
- The practice of violent sports
- Poor conditions of hygiene
- Professional environment of extreme cold or heat.
Sites / Locations
- CHU de BesanconRecruiting
- CHU de DijonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Intensified multiple injections
Pumps
Arm Description
Outcomes
Primary Outcome Measures
Mixed measurement of insulin secretion and insulin resistance
Secondary Outcome Measures
Decrease in the time spent in baseline and prandial hyperglycemia
Full Information
NCT ID
NCT02048189
First Posted
January 23, 2014
Last Updated
September 9, 2015
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT02048189
Brief Title
Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes
Acronym
TRICIDIA
Official Title
Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes: Study of Insulin Sensitivity in the 2 Types of Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
5. Study Description
Brief Summary
This is an open multicentre, randomized study to compare two treatment arms. One arm called "intensification of multiple injections" in which the patient will receive one supplementary injection of LEVEMIR®: that is to say 5 injections per day, and an arm called "continuous insulin infusion" via an external pump with APIDRA®.
In the pump arm: a favorable effect in terms of improved insulin sensitivity, improved metabolic equilibrium, a decrease in the area under the baseline and prandial hyperglycemia curve noted during the continuous glycemia recording; an improvement in quality of life compared with treatment using multiple injections.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensified multiple injections
Arm Type
Other
Arm Title
Pumps
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
LEVEMIR
Intervention Type
Drug
Intervention Name(s)
APIDRA
Primary Outcome Measure Information:
Title
Mixed measurement of insulin secretion and insulin resistance
Time Frame
Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment
Secondary Outcome Measure Information:
Title
Decrease in the time spent in baseline and prandial hyperglycemia
Time Frame
During the 6 months following initiation of the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Persons who have provided written informed consent
Age > 18 years
Patients with type 2 diabetes treated with insulin using a basal / bolus strategy for at least 6 months
Doses of insulin > 0.7 U / Kg / d
HbA1c ≥ 7.5 %
Without OAD for at least 4 weeks (sulfamides, Incretines, glinides, acarbose) except Metformin
BMI ≥ 28.5 kg / m2
Diabetes diagnosed for at least 10 years
Patients able to monitor themselves and manage an insulin pump.
Exclusion Criteria:
Patients treated with glitazones during the 3 months preceding inclusion
Patients with proliferative ischemic retinopathy not treated by laser
BMI < 28.5 kg / m2
Presence of implantable material ( CI MRI )
Pacemaker ( CI MRI )
Pregnancy, breast feeding
Medically significant physical or psychiatric inability, patients under guardianship or wards of court
The practice of violent sports
Poor conditions of hygiene
Professional environment of extreme cold or heat.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine BAILLOT-RUDONI
Phone
3.80.29.34.53
Ext
+33
Email
sabine.rudoni@chu-dijon.fr
Facility Information:
Facility Name
CHU de Besancon
City
Besancon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred PENFORMIS
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine BAILLOT-RUDONI
Phone
3.80.29.34.53
Ext
+33
Email
sabine.rudoni@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Isabelle SIMONEAU-ROBIN
Phone
3 80 29 33 32
Ext
+33
Email
isabelle.simoneau-robin@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes
We'll reach out to this number within 24 hrs