Linagliptin in Post-renal Transplantation

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

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

Study Overview

• Status: Completed
• Conditions: Transplanted Kidney Complication
• Intervention / Treatment: Drug: Linagliptin 5 mg Oral Tablet; Drug: Insulin

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.

• Study Type: Observational
• Enrollment (Actual): 28

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Post-transplanted renal patients with hyperglycemia in the hospital setting

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Linagliptin plus insulin; Patients that presented hyperglycemia immediately after renal transplantation and received treatment with linagliptin plus insulin	Drug: Linagliptin 5 mg Oral Tablet; Patients received linagliptin 5mg once daily orally plus a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl); Other Names: Linagliptin 5mg once daily plus insulin scheme
Insulin; Patients that presented hyperglycemia immediately after renal transplantation and received treatment only with insulin	Drug: Insulin; Patients received a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl); Other Names: Basal bolus insulin scheme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	Fasting glucose levels at day 5	5 days

Collaborators and Investigators

• Sponsor: Universidad de Guanajuato
• Collaborators: Hospital Regional de Alta Especialidad del Bajio
• Investigators: Principal Investigator: Rodolfo Guardado, MD, Hospital Regional de Alta Especialidad del Bajio

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): June 4, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Insulin; Insulin, Globin Zinc; Linagliptin
• Other Study ID Numbers: CEI-49-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: On a specific request we would be able to share data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No