Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174824

LTS6036

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 1,024 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)