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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00046462
Recruitment Status : Completed
First Posted : October 2, 2002
Last Update Posted : January 11, 2011
Information provided by:

September 30, 2002
October 2, 2002
January 11, 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 ]
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Complete list of historical versions of study NCT00046462 on Archive Site
  • Occurrence of hypoglycemia [ Time Frame: During the study conduct ]
  • Change in fasting plasma glucose [ Time Frame: During the study conduct ]
  • Percentage of patients achieving HbA1C less than or equal to 7% [ Time Frame: During the study conduct ]
  • Time to glycemic control [ Time Frame: During the study conduct ]
  • Change in body weight [ Time Frame: During the study conduct ]
  • Change in serum lipid profile [ Time Frame: During the study conduct ]
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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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: Lantus (insulin glargine [rDNA origin] injection)
  • Drug: Metformin
  • Drug: Glyburide
  • Drug: Thiazolidinedione
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Hollander P, Sugimoto D, Vlajnic A, Kilo C. Combination therapy with insulin glargine plus metformin but not insulin glargine plus sulfonylurea provides similar glycemic control to triple oral combination therapy in patients with type 2 diabetes uncontrolled with dual oral agent therapy. J Diabetes Complications. 2015 Nov-Dec;29(8):1266-71. doi: 10.1016/j.jdiacomp.2015.05.022. Epub 2015 Jun 5.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
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.

Sexes Eligible for Study: All
18 Years to 79 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Medical Affairs Study Director, sanofi-aventis
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Study Director: Doug Green Sanofi
January 2011

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