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
1 other identifier
interventional
1,024
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 diabetes-mellitus-type-2
Started Jun 2001
Longer than P75 for phase_4 diabetes-mellitus-type-2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedMarch 27, 2009
March 1, 2009
5.8 years
September 13, 2005
March 26, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The percentage of patients with a 3-step or greater progression in the patient
level recoded integer ETDRS retinopathy scale
Secondary Outcomes (4)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- prior treatment with insulin glargine
- treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (2)
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807, United States
Sanofi-Aventis Administrative Office
Laval, Canada
Related Publications (2)
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.
PMID: 33166419DERIVEDRosenstock 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.
PMID: 19526210DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ICD CSD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
June 1, 2001
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
March 27, 2009
Record last verified: 2009-03