Linagliptin in Post-renal Transplantation
Condition: Transplanted Kidney Complication
Study type: Observational

Summary: 
      Post-renal transplanted patients frequently present hyperglycemia immediately after the
      procedure.

      This was a retrospective comparative study performed in post-renal transplanted patients in a
      single high speciality center with the goal of compare the effect of linagliptin + insulin in
      post-renal transplanted patients with hyperglycemia Interventions were linagliptin 5mg daily
      plus insulin vs insulin alone during 5 days after renal transplantation with hyperglycemia,
      and the main outcome were glucose levels, insulin dose and severity of hypoglycemia
    

Detailed description: 
      This was a retrospective comparative study performed in a single center between 2016 and
      2018, included the data collected from 28 hospitalized post-renal transplanted patients that
      presented hyperglycemia (>140 mg/dl or or 7.77 mmol/l) immediately after renal
      transplantation (RT); 14 patients were treated with linagliptin 5mg daily plus a basal bolus
      insulin scheme prescribed by the Endocrinology group at the hospital, and 14 patients treated
      only with basal bolus insulin scheme were randomly selected from a list of patients treated
      during the same period of time and by the same Endocrinology group. Linagliptin dose was 5mg
      daily and the basal bolus insulin regimen was started and adjusted according to the
      international guidelines; in general, patients received a starting insulin dose of around 0.5
      U/kg/day, given half as basal insulin (NPH or Glargine) once or twice daily and half as
      insulin lispro divided into three equal doses before meals. Insulin dose was adjusted daily
      to achieve the goal of fasting glucose between 80-140 mg/dl (4.44-7.77 mmol/l) or random
      glucose levels below 180 mg/dl (9.99 mmol/l). Correctional insulin dose was used before each
      meal, depending on the glucose measurements, starting at 1 unit for each 40mg above 140 mg/dl
      (7.77 mmol/l) of glucose. Glucose levels were monitored at fasting and before each meal, as
      well as at bedtime according to standard clinical practice. Data regarding fasting and
      preprandial glucose levels, hypoglycemia, renal function, and immunosuppression therapy were
      recorded from the patient´s file during the first 5 days after RT; fasting glucose and renal
      function were also recorded at 1, 6 and 12 months after RT. Patients were included if they
      were between 18-65 years of age and presented fasting hyperglycemia (>140 mg/dl or 7.77
      mmol/l) immediately after RT.

      Ethical and Research committee (CEI) at the Hospital approved the study protocol with the
      number CEI-49-18.
    

Intervention name(s): Linagliptin 5 mg Oral Tablet; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Patients received linagliptin 5mg once daily orally plus a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl); Patients received a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl)
Other intervention name(s): Linagliptin 5mg once daily plus insulin scheme; Basal bolus insulin scheme
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Linagliptin
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Post-transplanted renal patients with hyperglycemia in the hospital setting