Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
Phase 3
Completed
- Conditions
- Diabetes Mellitus
- Registration Number
- NCT00046462
- Lead Sponsor
- Sanofi
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Change in body weight During the study conduct Change in serum lipid profile During the study conduct 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
Trial Locations
- Locations (1)
Aventis
🇺🇸Bridgewater, New Jersey, United States