Cost Effectiveness of Glargine Insulin Versus NPH Insulin
Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: insulin glargine (Drug); Insulin NPH (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Tehran University of Medical Sciences Official(s) and/or principal investigator(s): Alireza Esteghamati, M.D., Principal Investigator, Affiliation: Tehran University of Medical Sciences
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.
Clinical Details
Official title: Cost Effectiveness of Glargine Insulin Versus NPH Insulin in Diabetic Patients in Iran
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science
Primary outcome: Number Of Hypoglycemic events
Detailed description:
This was a randomized double blind controlled clinical trial of 12months on subjects with
type 2 diabetes. Two hundred diabetic subjects, 18-65 years of age, were included in the
study. Subjects were willing to initiate insulin therapy and had A1C >8. 0%. Any current and
prior medications were acceptable for participant inclusion other than any type of insulin
being evaluated. Demographic and anthropometric variables were recorded. Paraclinical data
including glucose and lipid profile were measured every three months. In addition, quality of
life was assessed with self-administered standard EQ-5D questionnaire.
Subjects were excluded for any of the following 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.
Participants were recruited between July 2011 and October 2012. They were randomly allocated
to two groups using a simple randomization method The insulin therapies were prescribed by a
physician in the clinic. The starting dose of insulin Glargine was 24 units per day (0. 2-0. 6
unit/kg) in 2 divided doses in the intervention group. The control group received NPH/Reg
insulin (2: 1) with initiation dose of 0. 2-0. 6 unit/kg in 2 divided doses. Two-thirds of the
dose was given before breakfast and the remainder before dinner. In the study, insulin
analogues were used in accordance with the licensed approval from the local regulatory
authority. Changes to OGLDs at the time of starting the insulin analogue, or thereafter,
were entirely at the discretion of the participant and physician. Paraclinical data were
measured in a referral laboratory every three months. Trial visits were defined as 0, 12,
24, 36 and 48 weeks from baseline. All participants were asked to record their 7-point blood
glucose values in three consecutive days before each visit. Seven-point self-monitoring
blood glucose includes three pre-meals, three post-meals, and bedtime blood glucose values
during each day. Insulin doses were adjusted by a titration regimen according to
self-monitored blood glucose. For both groups, treatment goals were as follows: fasting blood
glucose of 80-120 mg/dl, postprandial glucose <160 mg/dl, A1C<7% We collected medical costs
of each patient by a checklist. All patients had been asked to attend in our clinic every
one month during the study. Clinical events or hospital episodes and also all related costs
were determined at each visit. Any pharmaceutical, laboratory/diagnostic and rehabilitative
care, as well as any contact with specialists, general practitioners, nurses, opticians,
podiatrists, and dieticians were recorded for patients with/without complication. Finally
total costs were calculated.
Direct nonmedical costs:
Any services such as transportation for patients and their family to clinic and taking care
of dependents were assessed for non-medical expenditures by a patient self-estimate
questionnaire.
Indirect costs:
The lost productivity costs due to health problems of diabetes were determined by days
absent from work, poor work performance, low earnings capacity from disabilities, and
mortality. We calculated number of days in each visit who could not be present in their job
because of diabetes related health care. The average net hourly wage was asked from each
patient. For unemployed patients, we considered average wage of population who were
economically active and in employment. Lost earnings owing to premature mortality were
defined as the mortality costs. Costs from health provider perspective, were converted from
Iranian Rials (IRR) into USA dollar (USD) at an official exchange rate of 12,260 IRR/1USD
2012 to have an international comparison (Central Bank of Iran).
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Tehran University of Medical Sciences, Tehran 13145-784, Iran, Islamic Republic of
Additional Information
Starting date: July 2011
Last updated: April 15, 2013
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