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

Phase 4

Terminated

• Conditions: Patient With Type 2 Diabetes Treated With Insulin Using a Baseline/Bolus Strategy
• Interventions: Drug: APIDRA; Drug: LEVEMIR

• Registration Number: NCT02048189
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Study First Submitted: 2014-01-23
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-29
• Primary Completion: 2015-02-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pumps	APIDRA	-
Intensified multiple injections	LEVEMIR	-

Primary Outcome Measures

Name	Time	Method
Mixed measurement of insulin secretion and insulin resistance	Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment

Secondary Outcome Measures

Name	Time	Method
Decrease in the time spent in baseline and prandial hyperglycemia	During the 6 months following initiation of the treatment

Trial Locations

Locations (2)

CHU de Dijon; 🇫🇷 Dijon, France

CHU de Besancon; 🇫🇷 Besancon, France