Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00347100 |
Primary:
Secondary:
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: Insulin Glargine Drug: Glyburide Drug: Glyclazide Drug: Glimiperide Drug: Glipizide Drug: Metformin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Early Insulinization With Glargine in Type 2 Diabetes Patients Uncontrolled on Sulfonylurea or Metformin Monotherapy |
Enrollment: | 387 |
Study Start Date: | June 2006 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Administration of Insulin Glargine and Sulfonylurea or Metformin
|
Drug: Insulin Glargine
Throughout study period
Drug: Metformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
|
2: Active Comparator
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
|
Drug: Glyburide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Glyclazide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Glimiperide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Glipizide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Drug: Metformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
|
Ages Eligible for Study: | 18 Years to 80 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.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | LANTU_L_01051 |
Study First Received: | June 30, 2006 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00347100 |
Health Authority: | China: State Food and Drug Administration |
Glyburide Metabolic Diseases Glipizide Gliclazide Metformin Diabetes Mellitus Endocrine System Diseases |
Insulin Diabetes Mellitus, Type 2 Glargine Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |