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

Sanofi1 site in 1 country240 target enrollmentNovember 2001

ConditionsDiabetes Mellitus

DrugsLantus (insulin glargine [rDNA origin] injection)Metformin Glyburide Thiazolidinedione

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Sanofi
Enrollment: 240
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2001

End Date

December 2004

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Occurrence of hypoglycemia(During the study conduct)
Change in fasting plasma glucose(During the study conduct)
Percentage of patients achieving HbA1C less than or equal to 7%(During the study conduct)
Time to glycemic control(During the study conduct)
Change in body weight(During the study conduct)
Change in serum lipid profile(During the study conduct)