Cost Effectiveness of Glargine Insulin Versus NPH Insulin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alireza Esteghamati, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01832935
First received: April 11, 2013
Last updated: April 15, 2013
Last verified: April 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 Glargine insuline 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
Type 2 Diabetes Mellitus
Drug: insulin glargine
Drug: Insulin NPH
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Cost Effectiveness of Glargine Insulin Versus NPH Insulin in Diabetic Patients in Iran

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 months ] [ Designated as safety issue: No ]
    The Number Of Hypoglycemic Events That Happend For Patients During Taking Both Insulines


Enrollment: 200
Study Start Date: July 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: insulin glargine
patients receiving variable doses of Insulin glargine.start with 0.2 to 0.6unit per kg
Drug: insulin glargine
The starting dose of insulin Glargine was 24 units per day (0.2-0.6 unit/kg) in 2 divided doses
Other Name: Lantus
Active Comparator: Insulin NPH
patients receiving Variable doses Of Insulin NPH Start with 0.2 to 0.6 unit per kg
Drug: Insulin NPH
The starting dose of insulin NPH was 24 units per day (0.2-0.6 unit/kg) in 2 divided doses

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetes type 2
  • HbA1c 8% or higher
  • age 18 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01832935

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: Alireza Esteghamati, professor alireza esteghamati, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01832935     History of Changes
Other Study ID Numbers: 89-123
Study First Received: April 11, 2013
Last Updated: April 15, 2013
Health Authority: Iran: Ministry of Health and Medical Education

Keywords provided by Tehran University of Medical Sciences:
Glargin
NPH
Cost-effectiveness

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

ClinicalTrials.gov processed this record on July 09, 2014