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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01889095
First received: June 25, 2013
Last updated: June 27, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Diabetes Type 2
Drug: BIAsp 30
Drug: NPH/Reg
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Number Of Hypoglycemic events [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]

Enrollment: 160
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIAsp 30
patients receiving variable doses of Insulin BIAsp 30.start with 0.2 to 0.6unit per kg
Drug: BIAsp 30
patients receiving variable doses of Insulin BIAsp 30.start with 0.2 to 0.6unit per kg
Other Name: Novomix 30
Active Comparator: NPH/Reg
patients receiving Variable doses Of Insulin NPH Start with 0.2 to 0.6 unit per kg
Drug: NPH/Reg
patients receiving Variable doses Of Insulin NPH Start with 0.2 to 0.6 unit per kg
Other Name: NPH/Reg

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01889095

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 13145-784
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Alireza Esteghamati, M.D. Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01889095     History of Changes
Other Study ID Numbers: 90-03-33-15600
Study First Received: June 25, 2013
Last Updated: June 27, 2013
Health Authority: Iran: Tehran University of Medical Sciences, Tehran

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014