Diabetes Mellitus
Conditions
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.
Interventions
DRUGMetformin
DRUGGlyburide
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Change in fasting plasma glucose | During the study conduct |
| Percentage of patients achieving HbA1C less than or equal to 7% | During the study conduct |
| Occurrence of hypoglycemia | During the study conduct |
| Change in body weight | During the study conduct |
| Change in serum lipid profile | During the study conduct |
| Time to glycemic control | During the study conduct |
Countries
United States
Outcome results
None listed