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

NCT ID: NCT02048189

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-08

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensified multiple injections

Group Type: OTHER

LEVEMIR

Intervention Type: DRUG

Pumps

Group Type: OTHER

APIDRA

Intervention Type: DRUG

Interventions

LEVEMIR

Intervention Type: DRUG

APIDRA

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Besancon

Besançon, , France

CHU de Dijon

Dijon, , France

Countries

France

Other Identifiers

RUDONI PARI 2011

Identifier Type: -

Identifier Source: org_study_id