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

February 20, 2024 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besancon, France, 25000
        • CHU de Besancon
      • Dijon, France, 21079
        • CHU de DIJON

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intensified multiple injections
Drug: LEVEMIR
Other: Pumps
Drug: APIDRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Decrease in the time spent in baseline and prandial hyperglycemia
Time Frame: During the 6 months following initiation of the treatment
During the 6 months following initiation of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2012

Primary Completion (Actual)

February 26, 2015

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimated)

January 29, 2014

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RUDONI PARI 2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy

Clinical Trials on LEVEMIR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe