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

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ClinicalTrials.gov Identifier: NCT00468754
Recruitment Status : Completed
First Posted : May 3, 2007
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Device: Insulin pumps Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
Study Start Date : July 2003
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Device: Insulin pumps
Experimental: B Device: Insulin pumps



Primary Outcome Measures :
  1. Variability of blood glucose characterised by the standard deviation of the mean blood glucose [ Time Frame: Length of study ]

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


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00468754     History of Changes
Other Study ID Numbers: RD000275
RD000000275
First Posted: May 3, 2007    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: June 2010

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
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs