A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

Hoffmann-La Roche0 sites50 target enrollmentJuly 2003

ConditionsDiabetes Mellitus Type 1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus Type 1
Sponsor: Hoffmann-La Roche
Enrollment: 50
Primary Endpoint: Variability of blood glucose characterised by the standard deviation of the mean blood glucose
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

May 2005

Last Updated

10 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Type 1 diabetic patients, 18-60 years of age
•Diabetic for \>2 years
•Treated with CSII for \>=6 months
•HbA1c \<8.5%

Exclusion Criteria

•Treatment with daily insulin injections
•Inability to handle pump therapy
•Untreated retinopathy

Outcomes

Primary Outcomes

Variability of blood glucose characterised by the standard deviation of the mean blood glucose

Time Frame: Length of study

Secondary Outcomes

HbA1c(Length of study)
Frequency of severe hypoglycemia(Length of study)
Daily insulin requirement(Length of study)
Mean BG during the last month of the respective treatment period(Length of study)