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

Study Overview
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Brief Summary
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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.

Official Title
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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: Study of Insulin Sensitivity in the 2 Types of Treatment

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

Intervention / Treatment
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* Drug: LEVEMIR
* Drug: APIDRA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intensified multiple injections<br> | Drug: LEVEMIR<br> <br> |
| Other: Pumps<br> | Drug: APIDRA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in the time spent in baseline and prandial hyperglycemia |  | During the 6 months following initiation of the treatment |