| Trial ID: | L4221 |
| Source ID: | NCT00174824
|
| Associated Drug: |
Insulin Glargine
|
| Title: |
Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Insulin glargine
|
| Outcome Measures: |
Primary: The percentage of patients with a 3-step or greater progression in the patient|level recoded integer ETDRS retinopathy scale | Secondary: The percentage of patients who:develop proliferative retinopathy or develop clinically significant macular edema|the distribution of patients on the patient level recoded integer ETDRS retiopathy scale|the change from baseline in HbA1c and fasting plasma glucose|the incidence of hypoglycemia
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
1024
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2001-06
|
| Completion Date: |
2007-04
|
| Results First Posted: |
|
| Last Update Posted: |
2009-03-27
|
| Locations: |
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, 08807, United States|Sanofi-Aventis Administrative Office, Laval, Canada
|
| URL: |
https://clinicaltrials.gov/show/NCT00174824
|
