Back to resultsNovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes
Primary Purpose
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
insulin aspart
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes focused on measuring Diabetes Mellitus, Diabetes
Eligibility Criteria
Inclusion Criteria: People with Type I or Type II Diabetes 18 Years or Older.
Sites / Locations
- Novo Nordisk Investigational Site
Outcomes
Primary Outcome Measures
Treatment satisfaction with insulin pump therapy
Secondary Outcome Measures
body weight
Insulin dose
Overall glycemic control
number and types of infusion sets used.
infusion set in-use times
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00095446
Brief Title
NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes
Official Title
An Open-Label, Multi Center, Clinical Trial: External Continuous Subcutaneous Infusion of Insulin Using Insulin Aspart (NovoLog®) in Subjects With Type 1 and Insulin Requiring Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Keywords
Diabetes Mellitus, Diabetes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
513 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Primary Outcome Measure Information:
Title
Treatment satisfaction with insulin pump therapy
Secondary Outcome Measure Information:
Title
body weight
Title
Insulin dose
Title
Overall glycemic control
Title
number and types of infusion sets used.
Title
infusion set in-use times
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
People with Type I or Type II Diabetes
18 Years or Older.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR,1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18275357
Citation
Wittlin SD, Marcus AO, Weng CS, Howard CP, Schorr AB; CONTROL Study Group. Evaluation of treatment satisfaction associated with the use of insulin aspart in continuous subcutaneous insulin infusion. Diabetes Technol Ther. 2008 Feb;10(1):1-10. doi: 10.1089/dia.2007.0234.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes
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