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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00174824
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 27, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin glargine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1024 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin
Study Start Date : June 2001
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

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

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00174824

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00174824     History of Changes
Other Study ID Numbers: LTS6036
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 27, 2009
Last Verified: March 2009

Keywords provided by Sanofi:
Diabetic Retinopathy

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Retinal Diseases
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs