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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
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 ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: Length of study ]
  • Mean BG during the last month of the respective treatment period [ Time Frame: Length of study ]
  • Frequency of severe hypoglycemia [ Time Frame: Length of study ]
  • Daily insulin requirement [ Time Frame: Length of study ]

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)
Sexes Eligible for Study:   All

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
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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
Study First Received: May 2, 2007
Last Updated: March 1, 2016

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 Lispro
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017