Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients - Full Text View

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00174824

Purpose

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 IV

MedlinePlus related topics: Diabetes Diabetic Eye Problems Retinal Disorders

Drug Information available for: Insulin Insulin glargine Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin

Further study details as provided by Sanofi-Aventis:

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.

Eligibility

Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174824

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada
Sanofi-Aventis Administrative Office
Laval, Canada

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	LTS6036
Study First Received:	September 13, 2005
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00174824
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Sanofi-Aventis:

Diabetes
Diabetic Retinopathy

Study placed in the following topic categories:

Metabolic Diseases
Eye Diseases
Diabetes Mellitus
Disease Progression
Vascular Diseases
Endocrine System Diseases
Insulin, Isophane
Insulin
Diabetic Angiopathies

Diabetic Retinopathy
Diabetes Mellitus, Type 2
Glargine
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder
Retinal Diseases
Diabetes Complications

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009