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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00174824 |
To compare the progression of diabetic retinopathy in type 2 diabetic patients with mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 2 |
Drug: Insulin glargine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin |
Enrollment: | 1024 |
Study Start Date: | June 2001 |
Study Completion Date: | April 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Randomized, open-label assignment of type 2 patients who are on a stable antidiabetic regimen to treatment with either insulin glargine or BID NPH human insulin, with baseline diabetic retinopathy of severity 53/<53 on the ETDRS scale, for 5 years of followup. Outcomes measured by seven-field fundus photography at baseline, 1.5, 3,6,and 9 months, and annually.
Ages Eligible for Study: | 30 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New Jersey | |
Sanofi-aventis Administrative Office | |
Bridgewater, New Jersey, United States, 08807 | |
Canada | |
Sanofi-aventis Administrative Office | |
Laval, Canada |
Study Director: | ICD CSD | Sanofi-Aventis |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | LTS6036 |
Study First Received: | September 13, 2005 |
Last Updated: | March 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00174824 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Diabetes Diabetic Retinopathy |
Metabolic Diseases Eye Diseases Diabetes Mellitus Disease Progression Vascular Diseases Endocrine System Diseases Insulin, Isophane Insulin Diabetic Angiopathies |
Diabetic Retinopathy Hypoglycemic Agents Diabetes Mellitus, Type 2 Glargine Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Retinal Diseases Diabetes Complications |
Metabolic Diseases Eye Diseases Physiological Effects of Drugs Diabetes Mellitus Vascular Diseases Endocrine System Diseases Pharmacologic Actions Insulin Diabetic Angiopathies |
Diabetic Retinopathy Hypoglycemic Agents Diabetes Mellitus, Type 2 Glargine Cardiovascular Diseases Glucose Metabolism Disorders Retinal Diseases Diabetes Complications |