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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00046462
First received: September 30, 2002
Last updated: January 10, 2011
Last verified: January 2011

September 30, 2002
January 10, 2011
November 2001
November 2004   (final data collection date for 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 ]
Not Provided
Complete list of historical versions of study NCT00046462 on ClinicalTrials.gov Archive Site
  • 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 ]
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Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: Lantus (insulin glargine [rDNA origin] injection)
  • Drug: Metformin
  • Drug: Glyburide
  • Drug: Thiazolidinedione
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
December 2004
November 2004   (final data collection date for primary outcome measure)

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.

Both
18 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00046462
HOE901_4022
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Doug Green Sanofi
Sanofi
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP