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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: May 2, 2007
Last updated: March 1, 2016
Last verified: June 2010
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.

Condition Intervention
Diabetes Mellitus Type 1
Device: Insulin pumps

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Variability of blood glucose characterised by the standard deviation of the mean blood glucose [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Mean BG during the last month of the respective treatment period [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Frequency of severe hypoglycemia [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Daily insulin requirement [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2003
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Device: Insulin pumps
Experimental: B Device: Insulin pumps


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00468754

Bergamo, Italy, 24128
Brescia, Italy, 25123
Padova, Italy, 35128
Pisa, Italy, 56124
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Andreas Buhr Disetronic Medical Systems AG
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT00468754     History of Changes
Other Study ID Numbers: RD000275  RD000000275 
Study First Received: May 2, 2007
Last Updated: March 1, 2016
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin Glargine
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on October 21, 2016