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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Intensified multiple injections||
- 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 ]
- Decrease in the time spent in baseline and prandial hyperglycemia [ Time Frame: During the 6 months following initiation of the treatment ]
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
|Contact: Sabine BAILLOT-RUDONI||18.104.22.168.53 ext +firstname.lastname@example.org|
|CHU de Besancon||Recruiting|
|Besancon, France, 25000|
|Contact: Alfred PENFORMIS|
|CHU de Dijon||Recruiting|
|Dijon, France, 21079|
|Contact: Sabine BAILLOT-RUDONI 22.214.171.124.53 ext +33 email@example.com|
|Contact: Isabelle SIMONEAU-ROBIN 3 80 29 33 32 ext +33 firstname.lastname@example.org|