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Completed

NCT Number: NCT00174824

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Retinal Diseases Vascular Diseases

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sanofi-Aventis Administrative Office, Laval, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin glargine

Drug

Primary outcomes

  1. The percentage of patients with a 3-step or greater progression in the patient

  2. level recoded integer ETDRS retinopathy scale

Secondary outcomes

  1. The percentage of patients who:develop proliferative retinopathy or develop clinically significant macular edema

  2. the distribution of patients on the patient level recoded integer ETDRS retiopathy scale

  3. the change from baseline in HbA1c and fasting plasma glucose

  4. the incidence of hypoglycemia

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Sep 15, 2005
Registry last updated
Mar 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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