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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00174824
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2001-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-26
• Last Update Posted: 2009-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1024

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The percentage of patients with a 3-step or greater progression in the patient
level recoded integer ETDRS retinopathy scale

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇦 Laval, Canada