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

Tracking Information

First Received Date ^ICMJE

September 30, 2002

Last Updated Date

March 11, 2009

Start Date ^ICMJE

November 2001

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00046462 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Drug: Lantus (insulin glargine [rDNA origin] injection)
Drug: Metformin
Drug: Glyburide
Drug: Thiazolidinedione

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

240

Completion Date

December 2004

Primary Completion Date

November 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00046462

Responsible Party

Medical Affairs Study Director, sanofi-aventis

Study ID Numbers ^ICMJE

HOE901/4022

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Doug Green

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

March 2009

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