We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01889095
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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.

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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : July 2011
Primary Completion Date : August 2011
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Number Of Hypoglycemic events [ Time Frame: 3 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01889095     History of Changes
Other Study ID Numbers: 90-03-33-15600
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs