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

University Hospital Center (CHU) Dijon Bourgogne

Status and phase: Terminated; Phase 4

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

Treatments: Drug: LEVEMIR; Drug: APIDRA

Study type: Interventional

Funder types: Other

Identifiers

NCT02048189

RUDONI PARI 2011

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

14 participants in 2 patient groups

Intensified multiple injections

Other group

Treatment:

Drug: LEVEMIR

Pumps

Other group

Treatment:

Drug: APIDRA