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Cost Effectiveness of Glargine Insulin Versus NPH Insulin

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ClinicalTrials.gov Identifier: NCT01832935
Recruitment Status : Completed
First Posted : April 16, 2013
Last Update Posted : April 16, 2013
Sponsor:
Information provided by (Responsible Party):
Alireza Esteghamati, 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 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 or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: insulin glargine Drug: Insulin NPH Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Cost Effectiveness of Glargine Insulin Versus NPH Insulin in Diabetic Patients in Iran
Study Start Date : July 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number Of Hypoglycemic events [ Time Frame: 3 months ]
    The Number Of Hypoglycemic Events That Happend For Patients During Taking Both Insulines



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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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): 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

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
First Posted: April 16, 2013    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: April 2013

Keywords provided by Alireza Esteghamati, 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
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Glargine
Insulin, Isophane
Isophane Insulin, Human
Hypoglycemic Agents
Physiological Effects of Drugs