Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00468754
First received: May 2, 2007
Last updated: August 26, 2014
Last verified: June 2010
  Purpose

This trial will compare the metabolic control in type 1 diabetes obtained by con tinuous infusion of insulin lispro with that obtained by multiple daily injectio ns 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00468754

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00468754     History of Changes
Other Study ID Numbers: RD000275, RD000000275
Study First Received: May 2, 2007
Last Updated: August 26, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Insulin
Insulin Lispro
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014