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

This study has been completed.

First Received: May 2, 2007 No Changes Posted

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00468754

Purpose

This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin Lispro with that obtained by multiple 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.

Condition	Intervention
Diabetes Mellitus, Type 1	Device: Insulin pumps

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin lispro

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study
Official Title:	Comparison Between CSII With Multiple Basal Lispro Infusion Rates and MDI With Lispro and Glargine

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Blood glucose variability.

Secondary Outcome Measures:

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

Study Start Date:

July 2003

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468754

Locations

Italy

Bergamo, Italy

Brescia, Italy

Padova, Italy

Pisa, Italy

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Study ID Numbers:	RD000000275, RD000000275-2007
Study First Received:	May 2, 2007
Last Updated:	May 2, 2007
ClinicalTrials.gov Identifier:	NCT00468754 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Diabetes Mellitus
Endocrine System Diseases
Insulin LISPRO
Diabetes Mellitus Type 1
Insulin

Hypoglycemic Agents
Diabetes Mellitus, Type 1
Glargine
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Hypoglycemic Agents
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 06, 2009