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

U

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

Trial contacts and locations

2

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Central trial contact

Sabine BAILLOT-RUDONI

Data sourced from clinicaltrials.gov

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