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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00174824
• Other study ID #: LTS6036
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: March 26, 2009
• Start date: June 2001
• Est. completion date: April 2007

Study information

• Verified date: March 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1024
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Insulin glargine

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with a 3-step or greater progression in the patient
Primary	level recoded integer ETDRS retinopathy scale
Secondary	The percentage of patients who:develop proliferative retinopathy or develop clinically significant macular edema
Secondary	the distribution of patients on the patient level recoded integer ETDRS retiopathy scale
Secondary	the change from baseline in HbA1c and fasting plasma glucose
Secondary	the incidence of hypoglycemia