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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00046462 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: Lantus (insulin glargine [rDNA origin] injection) Drug: Metformin Drug: Glyburide Drug: Thiazolidinedione |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 240 |
| Study Start Date: | November 2001 |
| Study Completion Date: | December 2004 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
| Study ID Numbers: | HOE901/4022 |
| Study First Received: | September 30, 2002 |
| Last Updated: | March 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00046462 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Glyburide Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Metformin Glargine |
Diabetes Mellitus 2,4-thiazolidinedione Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions Insulin |