Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Diabetic Retinopathy
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.
Interventions
DRUGInsulin glargine
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of patients with a 3-step or greater progression in the patient | — |
| level recoded integer ETDRS retinopathy scale | — |
Secondary
| Measure | Time frame |
|---|---|
| the change from baseline in HbA1c and fasting plasma glucose | — |
| the incidence of hypoglycemia | — |
| the distribution of patients on the patient level recoded integer ETDRS retiopathy scale | — |
| The percentage of patients who:develop proliferative retinopathy or develop clinically significant macular edema | — |
Countries
Canada, United States
Outcome results
None listed