Text Size

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: May 23, 2013
Last verified: June 2010
History of Changes

May 2, 2007
May 23, 2013
July 2003
May 2005   (final data collection date for primary outcome measure)
Variability of blood glucose characterised by the standard deviation of the mean blood glucose [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Blood glucose variability.
Complete list of historical versions of study NCT00468754 on ClinicalTrials.gov Archive Site
  • 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 ]
  • HbA1c
  • Mean BG during the last month of the respective treatment period
  • Frequency of severe hypoglycemia
  • Daily insulin requirement
Not Provided
Not Provided
 
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes Mellitus, Type 1
Device: Insulin pumps
  • Experimental: A
    Intervention: Device: Insulin pumps
  • Experimental: B
    Intervention: Device: Insulin pumps
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2005
May 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00468754
RD000275, RD000000275
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Andreas Buhr Disetronic Medical Systems AG
Hoffmann-La Roche
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP