Cost Effectiveness of Glargine Insulin Versus NPH Insulin
Cost Effectiveness of Glargine Insulin Versus NPH Insulin
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.
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).
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.