Bridgewater, New Jersey 08807

  • Diabetes Mellitus, Type 2

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - type 2 diabetes mellitus for at least 1 year - treated with oral antidiabetic agents or insulin at stable doses for at least 3 months - HbA1c between 6 and 12% inclusive - baseline retinopathy severity not to exceed 53/<53 on the ETDRS scale - unlikely to require laser surgery or vitrectomy within upcoming year Exclusion Criteria: - prior treatment with insulin glargine - treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment


NCT ID:

NCT00174824


Primary Contact:

Study Director
ICD CSD
Sanofi-Aventis


Backup Contact:

N/A


Location Contact:

Bridgewater, New Jersey 08807
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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