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Treatment With Continuous Sub-cutaneous Insulin Infusion Via a Portable Pump Versus Discontinuous Insulin Infusion Via Multiple-injections in Type 2 Diabetes (TRICIDIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02048189
Recruitment Status : Unknown
Verified September 2015 by Centre Hospitalier Universitaire Dijon.
Recruitment status was:  Recruiting
First Posted : January 29, 2014
Last Update Posted : September 10, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

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.


Condition or disease Intervention/treatment Phase
Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy Drug: LEVEMIR Drug: APIDRA Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2012
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intensified multiple injections Drug: LEVEMIR
Pumps Drug: APIDRA



Primary Outcome Measures :
  1. 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 Measures :
  1. Decrease in the time spent in baseline and prandial hyperglycemia [ Time Frame: During the 6 months following initiation of the treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048189


Contacts
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Contact: Sabine BAILLOT-RUDONI 3.80.29.34.53 ext +33 sabine.rudoni@chu-dijon.fr

Locations
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France
CHU de Besancon Recruiting
Besancon, France, 25000
Contact: Alfred PENFORMIS         
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Sabine BAILLOT-RUDONI    3.80.29.34.53 ext +33    sabine.rudoni@chu-dijon.fr   
Contact: Isabelle SIMONEAU-ROBIN    3 80 29 33 32 ext +33    isabelle.simoneau-robin@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02048189     History of Changes
Other Study ID Numbers: RUDONI PARI 2011
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: September 10, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs