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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00642915 |
To estimate the efficacy of combination therapy with Lantus plus Amaryl in controlling blood glucose in Japanese patients with type 2 diabetes having failed OAD therapy, and document the ability to preserve the endocrine pancreatic function with Lantus plus Amaryl combination therapy
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus |
Drug: Lantus, Amaryl |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | A 24 Week, Open-Label, Single Arm, Multi-Center Clinical Study to Document the Benefits of the Combination of Lantus and Amaryl in Ethnic Japanese Type 2 Diabetic Patients Living Outside of Japan (in US or Brazil), Who Failed Good Metabolic Control With Oral Antidiabetic Drugs (OADs) |
Enrollment: | 100 |
Study Start Date: | June 2003 |
Study Completion Date: | July 2004 |
Ages Eligible for Study: | 20 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Responsible Party: | Sanofi-Aventis ( Study Director ) |
Study ID Numbers: | HOE901_4039 |
Study First Received: | March 19, 2008 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00642915 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research |
Glimepiride Hypoglycemic Agents Metabolic Diseases Glargine Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Hypoglycemic Agents Metabolic Diseases Physiological Effects of Drugs Glargine |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |