Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 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 3
Status: Completed
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Doug Green, Study Director, Affiliation: Sanofi
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Occurrence of hypoglycemiaChange in fasting plasma glucose Percentage of patients achieving HbA1C less than or equal to 7% Time to glycemic control Change in body weight Change in serum lipid profile
Eligibility
Minimum age: 18 Years.
Maximum age: 79 Years.
Gender(s): Both.
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.
Locations and Contacts
Aventis, Bridgewater, New Jersey 08807, United States
Additional Information
Starting date: November 2001
Last updated: January 10, 2011
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