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

NCT00046462 Phase 3 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 3
Status	COMPLETED
Enrolment	240
Start date	2001-11
Completion	2004-12

Conditions

• Diabetes Mellitus

Interventions

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

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 — During the Study Conduct

Countries

United States