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

NCT01889095 | Completed Phase 4

• 1 other identifier: 90-03-33-15600
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

• Number Of Hypoglycemic events

  3 month

Study Arms (2)

BIAsp 30

EXPERIMENTAL

patients receiving variable doses of Insulin BIAsp 30.start with 0.2 to 0.6unit per kg

Drug: BIAsp 30

NPH/Reg

ACTIVE COMPARATOR

patients receiving Variable doses Of Insulin NPH Start with 0.2 to 0.6 unit per kg

Drug: NPH/Reg

Interventions

BIAsp 30 DRUG

patients receiving variable doses of Insulin BIAsp 30.start with 0.2 to 0.6unit per kg

Also known as: Novomix 30

BIAsp 30

NPH/Reg DRUG

patients receiving Variable doses Of Insulin NPH Start with 0.2 to 0.6 unit per kg

NPH/Reg

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diabetes type 2
• HbA1c 8% or higher
• age 25 to 65

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Tehran Province, 13145-784, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Alireza Esteghamati, M.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2013
• First Posted: June 28, 2013
• Study Start: July 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: July 1, 2012
• Last Updated: June 28, 2013

Record last verified: 2013-06

Locations

IR (1)