Status:
COMPLETED
Cost Effectiveness of Glargine Insulin Versus NPH Insulin
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Glycemic control is fundamental in the management of diabetes mellitus .If lifestyle intervention and full tolerated doses of one or two oral glucose lowering drugs (OGLDs) fail to achieve or sustain ...
Detailed Description
This was a randomized double blind controlled clinical trial of 12months on subjects with type 2 diabetes. Two hundred diabetic subjects, 18-65 years of age, were included in the study. Subjects were ...
Eligibility Criteria
Inclusion
- diabetes type 2
- HbA1c 8% or higher
- age 18 to 65
Exclusion
- alteration in insulin sensitivity such as major surgery, infection, renal failure (Glomerular Filtration Rate \< 50),
- glucocorticoid treatment,
- recent (within 2 weeks) serious hypoglycemic episode (requires assistance of another),
- simultaneous participating in another clinical study,
- using any type of insulin,
- sight or hearing impaired,
- active proliferative retinopathy or maculopathy require treatment within 6 months prior to screening,
- breast feeding,
- pregnancy or nursing of the intention of becoming pregnant or
- not using adequate contraceptive measures.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01832935
Start Date
July 1 2011
End Date
July 1 2012
Last Update
April 16 2013
Active Locations (1)
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1
Tehran University of Medical Sciences
Tehran, Tehran Province, Iran, 13145-784