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Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

This study has been completed.
Study NCT00046462.   Last updated on July 28, 2008.   Information provided by Sanofi-Aventis

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
Official Title  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
Brief Summary

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.

Detailed Description
Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  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 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Occurrence of hypoglycemia [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Change in fasting plasma glucose [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Percentage of patients achieving HbA1C less than or equal to 7% [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Time to glycemic control [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Change in body weight [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Change in serum lipid profile [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Condition  Diabetes Mellitus
Intervention  Drug: Lantus (insulin glargine [rDNA origin] injection)
Drug: Metformin
Drug: Glyburide
Drug: Thiazolidinedione
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  240
Start Date  November 2001
Completion Date December 2004
Eligibility Criteria 

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.

Gender Both
Ages 18 Years to 79 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00046462
Organization ID HOE901/4022
Secondary IDs ††
Study Sponsor  Sanofi-Aventis
Collaborators ††
Investigators 
Study Director:     Doug Green     Sanofi-Aventis    
Information Provided By Sanofi-Aventis
Verification Date July 2008
First Received Date  September 30, 2002
Last Updated Date July 28, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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