- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00772356
A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Insulin Infusion in Patients With Type I Diabetes
March 1, 2016 updated by: Hoffmann-La Roche
This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen.
Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes.
On the second study day they will be switched to treatment with the alternative delivery regimen.
The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Neuss, Germany, 41460
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male patients 18-65 years of age
- Type I diabetes mellitus
- Currently on continuous subcutaneous insulin infusion therapy
Exclusion Criteria:
- Proliferative retinopathy or maculopathy requiring actue treatment within last 6 months
- Use of systemic corticoids in last 3 months
- Treatment with medication known to interfere with glucose metabolism
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: B
|
|
Experimental: A
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparison of glucose infusion rate necessary to keep blood glucose constant
Time Frame: Throughout study
|
Throughout study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum insulin and free fatty acid levels
Time Frame: Throughout study
|
Throughout study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bettina Dr. Petersen, Roche Diagnostics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
October 13, 2008
First Submitted That Met QC Criteria
October 14, 2008
First Posted (Estimate)
October 15, 2008
Study Record Updates
Last Update Posted (Estimate)
March 3, 2016
Last Update Submitted That Met QC Criteria
March 1, 2016
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD000559
- 05/0377-Basal
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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