Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: Lantus (insulin glargine [rDNA origin] injection) (Drug); Metformin (Drug); Glyburide (Drug); Thiazolidinedione (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Sanofi-Aventis
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
Key Inclusion:
- 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.
Key Exclusion:
- Major cardiovascular events
Locations and Contacts
Aventis, Bridgewater, New Jersey 08807, United States
Additional Information
Starting date: November 2001
Last updated: September 23, 2005
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