- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00046462
Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
January 10, 2011 updated by: Sanofi
Substituting Lantus®(Insulin Glargine[rDNAorigin]Inj) for a Thiazolidinedione vs. a 3rd Oral Agent as add-on Therapy in Patients Failing a Thiazolidinedione & Sulfonylurea or Metformin Combination
The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
240
Phase
- Phase 3
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
-
-
New Jersey
-
Bridgewater, New Jersey, United States, 08807
- Aventis
-
-
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 79 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients between 18 - 79 years of age
- With diagnosed type 2 diabetes for at least a year treated with stable doses of two oral antidiabetic drugs of which one is either Avandia or Actos for at least three months
Exclusion Criteria:
- Major cardiovascular events
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy
Time Frame: During the Study Conduct
|
During the Study Conduct
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of hypoglycemia
Time Frame: During the study conduct
|
During the study conduct
|
Change in fasting plasma glucose
Time Frame: During the study conduct
|
During the study conduct
|
Percentage of patients achieving HbA1C less than or equal to 7%
Time Frame: During the study conduct
|
During the study conduct
|
Time to glycemic control
Time Frame: During the study conduct
|
During the study conduct
|
Change in body weight
Time Frame: During the study conduct
|
During the study conduct
|
Change in serum lipid profile
Time Frame: During the study conduct
|
During the study conduct
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Doug Green, Sanofi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
November 1, 2001
Primary Completion (Actual)
November 1, 2004
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
September 30, 2002
First Submitted That Met QC Criteria
October 1, 2002
First Posted (Estimate)
October 2, 2002
Study Record Updates
Last Update Posted (Estimate)
January 11, 2011
Last Update Submitted That Met QC Criteria
January 10, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOE901_4022
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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