Back to resultsA Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
Primary Purpose
Diabetes Mellitus Type 1
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Insulin pumps
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus Type 1
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
Variability of blood glucose characterised by the standard deviation of the mean blood glucose
Secondary Outcome Measures
HbA1c
Mean BG during the last month of the respective treatment period
Frequency of severe hypoglycemia
Daily insulin requirement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00468754
Brief Title
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
Official Title
A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Insulin pumps
Primary Outcome Measure Information:
Title
Variability of blood glucose characterised by the standard deviation of the mean blood glucose
Time Frame
Length of study
Secondary Outcome Measure Information:
Title
HbA1c
Time Frame
Length of study
Title
Mean BG during the last month of the respective treatment period
Time Frame
Length of study
Title
Frequency of severe hypoglycemia
Time Frame
Length of study
Title
Daily insulin requirement
Time Frame
Length of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Buhr
Organizational Affiliation
Disetronic Medical Systems AG
Official's Role
Study Director
Facility Information:
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Brescia
ZIP/Postal Code
25123
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Pisa
ZIP/Postal Code
56124
Country
Italy
12. IPD Sharing Statement
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A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
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