Biphasic Insulin Aspart Versus NPH Plus Regular Human Insulin in Type 2 Diabetic Patients

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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 glycemic goals, insulin should be initiated. New insulin analogs are generated to improve glycemic control .New insulin analogs are generated to improve glycemic control,However, the cost of these analogs is a major problem .The aim of this piggy back evaluation was to assess the effect of BIAsp 30 versus NPH plus regular human insulin on metabolic control as well as its cost-effectiveness in people with type 2 diabetes in the Iranian setting.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Treatments: Insulin; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• diabetes type 2

• HbA1c 8% or higher

• age 25 to 65

Exclusion Criteria:

• 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.