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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: September 13, 2005
Last updated: March 26, 2009
Last verified: March 2009
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.

Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin glargine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The percentage of patients with a 3-step or greater progression in the patient
  • level recoded integer ETDRS retinopathy scale

Secondary Outcome Measures:
  • 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

Enrollment: 1024
Study Start Date: June 2001
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts 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
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Please refer to this study by its identifier: NCT00174824

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Laval, Canada
Sponsors and Collaborators
Study Director: ICD CSD Sanofi
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00174824     History of Changes
Other Study ID Numbers: LTS6036 
Study First Received: September 13, 2005
Last Updated: March 26, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Sanofi:
Diabetic Retinopathy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetic Retinopathy
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on May 03, 2016