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NCT00468754 Clinical Trial

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

Diabetes Mellitus Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00468754
Other study ID # RD000275
Secondary ID RD000000275
Status Completed
Phase N/A
First received May 2, 2007
Last updated March 1, 2016
Start date July 2003
Est. completion date May 2005

Study information
Verified date June 2010
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date May 2005
Est. primary completion date May 2005
Accepts healthy volunteers
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Insulin pumps

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Variability of blood glucose characterised by the standard deviation of the mean blood glucose Length of study No
Secondary HbA1c Length of study No
Secondary Mean BG during the last month of the respective treatment period Length of study No
Secondary Frequency of severe hypoglycemia Length of study No
Secondary Daily insulin requirement Length of study No
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