Status:
COMPLETED
Biphasic Insulin Aspart Versus NPH Plus Regular Human Insulin in Type 2 Diabetic Patients
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Diabetes Type 2
Eligibility:
All Genders
25-65 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
Study design and participants This was a randomized controlled clinical trial of 48 weeks on subjects with T2DM between July 2011 and October 2012. Two hundred and four diabetic subjects aged 28-65 ye...
Eligibility Criteria
Inclusion
- diabetes type 2
- HbA1c 8% or higher
- age 25 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 :
160 Patients enrolled
Trial Details
Trial ID
NCT01889095
Start Date
July 1 2011
End Date
July 1 2012
Last Update
June 28 2013
Active Locations (1)
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1
Tehran University of Medical Sciences
Tehran, Tehran Province, Iran, 13145-784