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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00174824
First received: September 13, 2005
Last updated: March 26, 2009
Last verified: March 2009

September 13, 2005
March 26, 2009
June 2001
April 2007   (final data collection date for primary outcome measure)
  • The percentage of patients with a 3-step or greater progression in the patient
  • level recoded integer ETDRS retinopathy scale
The percentage of patients with a 3-step or greater progression in the patient level recoded integer ETDRS retinopathy scale
Complete list of historical versions of study NCT00174824 on ClinicalTrials.gov Archive Site
  • 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
  • the percentage of patients who:
  • - develop proliferative retinopathy
  • - 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
Not Provided
Not Provided
 
Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients
Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
Drug: Insulin glargine
Not Provided
Rosenstock J, Fonseca V, McGill JB, Riddle M, Hallé JP, Hramiak I, Johnston P, Davis M. Similar progression of diabetic retinopathy with insulin glargine and neutral protamine Hagedorn (NPH) insulin in patients with type 2 diabetes: a long-term, randomised, open-label study. Diabetologia. 2009 Sep;52(9):1778-88. Epub 2009 Jun 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1024
April 2007
April 2007   (final data collection date for primary outcome measure)

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
Both
30 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00174824
LTS6036
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP