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Effect of Insulin Glulisine Compared to Insulin Aspart and Insulin Lispro When Administered by Continuous Subcutaneous Insulin Infusion (CSII) on Specific Pump Parameters in Patient With Type 1 Diabetes Mellitus

NCT00607087 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2010-08-31

Study results available
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Summary

Primary objective: To demonstrate the superiority of insulin glulisine over insulin aspart and insulin lispro administered by external pump in term of unexplained hyperglycemia and/or infusion set occlusion.

Main Secondary objectives:

To compare insulin glulisine, insulin aspart and insulin lispro on:

* Unexplained hyperglycemia
* Infusion set occlusion
* Hypoglycemic episodes,7-point blood glucose profiles
* Episodes of significant ketosis and/or risk level for impending diabetic ketoacidosis
* Time to change the infusion set
* HbA1c (Glycosylated hemoglobin)
* Overall safety: incidence of adverse events

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Insulin glulisine

100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

DRUG

Insulin lispro

100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

DRUG

Insulin aspart

100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump

Sponsors & Collaborators

Principal Investigators

  • Medical Affairs · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States
  • Australia
  • Austria
  • France
  • Hungary
  • Israel
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00607087 on ClinicalTrials.gov