Cost Effectiveness of Glargine Insulin Versus NPH Insulin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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.
    

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).
    

Intervention name(s): insulin glargine; Insulin NPH
Intervention type(s): Drug; Drug
Intervention description(s): The starting dose of insulin Glargine was 24 units per day (0.2-0.6 unit/kg) in 2 divided doses; The starting dose of insulin NPH was 24 units per day (0.2-0.6 unit/kg) in 2 divided doses
Other intervention name(s): Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Glargin; NPH; Cost-effectiveness