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Linagliptin in Post-renal Transplantation

Linagliptin Plus Insulin for Hyperglycemia Immediately After Renal Transplantation: A Comparative Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03970668
Enrollment
28
Registered
2019-05-31
Start date
2016-01-01
Completion date
2019-04-30
Last updated
2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplanted Kidney Complication

Brief 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.

Interventions

Patients received linagliptin 5mg once daily orally plus a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl)

DRUGInsulin

Patients received a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl)

Sponsors

Hospital Regional de Alta Especialidad del Bajio
CollaboratorOTHER
Universidad de Guanajuato
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Hyperglycemia (glucose levels above 140 mg/dl) immediately after renal transplantation

Exclusion criteria

* Incomplete records on the patients file * Acute complications such as liver failure

Design outcomes

Primary

MeasureTime frameDescription
Fasting glucose5 daysFasting glucose levels at day 5

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026