Back to resultsComparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Insulin glargine
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Diabetic Retinopathy
Eligibility 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
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00174824
Brief Title
Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients
Official Title
Evaluation of Diabetic Retinopathy Progression in Subjects With Type 2 Diabetes Mellitus Treated With Insulin
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes, Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1024 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Primary Outcome Measure Information:
Title
The percentage of patients with a 3-step or greater progression in the patient
Title
level recoded integer ETDRS retinopathy scale
Secondary Outcome Measure Information:
Title
The percentage of patients who:develop proliferative retinopathy or develop clinically significant macular edema
Title
the distribution of patients on the patient level recoded integer ETDRS retiopathy scale
Title
the change from baseline in HbA1c and fasting plasma glucose
Title
the incidence of hypoglycemia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Laval
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
33166419
Citation
Semlitsch T, Engler J, Siebenhofer A, Jeitler K, Berghold A, Horvath K. (Ultra-)long-acting insulin analogues versus NPH insulin (human isophane insulin) for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD005613. doi: 10.1002/14651858.CD005613.pub4.
Results Reference
derived
PubMed Identifier
19526210
Citation
Rosenstock J, Fonseca V, McGill JB, Riddle M, Halle 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. doi: 10.1007/s00125-009-1415-7. Epub 2009 Jun 13.
Results Reference
derived
Learn more about this trial
Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients
We'll reach out to this number within 24 hrs