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

NCT02048189 | Terminated Phase 4

• 1 other identifier: RUDONI PARI 2011
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Mixed measurement of insulin secretion and insulin resistance

  Change from baseline insulin secretion and insuline resistance at 6 month after starting the treatment

Secondary Outcomes (1)

• Decrease in the time spent in baseline and prandial hyperglycemia

  During the 6 months following initiation of the treatment

Study Arms (2)

Intensified multiple injections

OTHER

Drug: LEVEMIR

Pumps

OTHER

Drug: APIDRA

Interventions

LEVEMIR DRUG

Intensified multiple injections

APIDRA DRUG

Pumps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (2)

CHU de Besancon

Besançon, 25000, France

Location

CHU de Dijon

Dijon, 21079, France

Location

MeSH Terms

Interventions

Insulin Detemir; insulin glulisine

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 29, 2014
• Study Start: March 8, 2012
• Primary Completion: February 26, 2015
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

FR (2)