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

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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

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.