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

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

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02048189
• Other study ID #: RUDONI PARI 2011
• Status: Terminated
• Phase: Phase 4
• Start date: March 8, 2012

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. primary completion date: February 26, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy

Intervention

Drug:
• LEVEMIR

• APIDRA

Locations

Country	Name	City	State
France	CHU de Besancon	Besancon
France	CHU de Dijon	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mixed measurement of insulin secretion and insulin resistance		Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment
Secondary	Decrease in the time spent in baseline and prandial hyperglycemia		During the 6 months following initiation of the treatment