Linagliptin Inpatient Trial

February 18, 2019 updated by: Guillermo Umpierrez, MD, Emory University

Linagliptin Inpatient Trial: A Randomized Controlled Trial on the Safety and Efficacy of Linagliptin (Tradjenta®) Therapy for the Inpatient Management of General Surgery Patients With Type 2 Diabetes

This study is a prospective, randomized, open label trial to compare the safety and efficacy of linagliptin (an oral anti diabetic medication) given orally once daily to an insulin regimen of glargine once daily plus rapid-acting insulin before meals. Both of these treatment groups will be given corrective doses of rapid-acting insulin analogs (aspart, lispro or glulisine) before meals if their blood sugars are > 140 mg/dl.

The patients will be monitored for their blood sugars while the hospital.

If patients are agreeable to participate in the discharge part of the study, the investigators will randomized them to a treatment group based on their admission HbA1c. The investigators will follow these patients for 3 months with phone calls and clinic visits, and will monitor their blood sugars. This is to compare the efficacy of linagliptin and our discharge treatment algorithm in controlling blood sugars as out patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Specific Aim 1: To determine whether in-hospital glycemic control, as measured by mean daily glucose concentration and frequency of hypoglycemic events, is different between treatment with linagliptin (Tradjenta®) plus correction doses with a rapid-acting insulin analog before meals and a basal bolus regimen with glargine once daily and rapid-acting insulin analog before meals in general surgery patients with T2D.

Specific Aim 2: To determine the efficacy and safety of an A1C based discharge algorithm in controlling BG after discharge in patients with T2D. Patients who participate in the in-hospital arm (Aim 1) will be invited to enroll in this open label prospective outpatient study. The total duration of the study is 3 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
295

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80220
        • University of Colorado
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States
        • Grady Memorial Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males or female surgical non-ICU patients ages between18 and 80 years
  2. A known history of T2D > 1 month, receiving either diet alone, oral antidiabetic agents: sulfonylureas and metformin as monotherapy or in combination therapy (excluding DPP-4 inhibitors) or low-dose (≤ 0.5 units/kg/day) insulin therapy.
  3. Subjects with a BG >140 mg and < 400 mg/dL at time of randomization without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones)

Exclusion Criteria:

  1. Age < 18 or > 80 years.
  2. Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
  3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 requiring insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state, or ketonuria) (43).
  4. Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
  5. Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
  6. Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
  7. Patients with clinically relevant pancreatic or gallbladder disease.
  8. Patients with previous history of pancreatitis
  9. Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).
  10. Chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
  11. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  12. Pregnancy or breast feeding at time of enrollment into the study.
  13. Patients who received supplemental sliding scale insulin >72 hours prior to randomization
  14. Patients who received basal insulin > 48 hours prior to randomization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Linagliptin In-hospital
Linagliptin once daily+ correction doses of aspart or lispro if needed
Drug: Linagliptin
Linagliptin once daily + correction doses of rapid acting insulin if needed
Other Names:
  • Tradjenta
Drug: Linagliptin
Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.
Other Names:
  • Trajenta
Active Comparator: Basal Bolus In-hospital
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Drug: Basal Bolus
Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed
Other Names:
  • Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)
Experimental: Linagliptin on discharge
Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day. If contraindication to oral anti-diabetics (OAD), discharge patient on linagliptin once daily.
Drug: Linagliptin
Linagliptin once daily + correction doses of rapid acting insulin if needed
Other Names:
  • Tradjenta
Drug: Linagliptin
Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.
Other Names:
  • Trajenta
Experimental: Linagliptin+50%Glargine dose on d/c
Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.
Drug: Linagliptin + 50% Glargine dose on discharge
Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.
Other Names:
  • Trajenta, Lantus
Experimental: Linagliptin+80%Glargine dose on d/c
Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose. Patient who did not receive glargine in the hospital, discharge on previous OAD + linagliptin once daily, and consider starting glargine at 0.15 unit/kg/day.
Drug: Linagliptin + 80% Glargine
Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.
Other Names:
  • Trajenta, Lantus

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Differences in Glycemic Control
Time Frame: Inpatient (average 5 days) and outpatient up to 12 weeks
Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
Inpatient (average 5 days) and outpatient up to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hypoglycemia <70 mg/dl
Time Frame: Inpatient (average 5 days) and outpatient up to 12 weeks
Subjects with Hypoglycemia <70 mg/dl
Inpatient (average 5 days) and outpatient up to 12 weeks
Hyperglycemia
Time Frame: Inpatient (average 5 days) and outpatient up to 12 weeks
Subjects with BG > 300 mg/dl
Inpatient (average 5 days) and outpatient up to 12 weeks
Daily Dose of Insulin
Time Frame: Inpatient (average 5 days) and outpatient up to 12 weeks
Total daily dose of insulin
Inpatient (average 5 days) and outpatient up to 12 weeks
Length of Hospital Stay
Time Frame: During Hospitalization
Length of hospital stay (ONLY for inpatient arms 1 and 2)
During Hospitalization
Number of Participants Requiring ICU Care During Hospitalization
Time Frame: During Hospitalization-average 5 days
Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization
During Hospitalization-average 5 days
Hospital Complications
Time Frame: During Hospitalization-average 5 days
Subjects with composite complication (ONLY for inpatient arms 1 and 2)
During Hospitalization-average 5 days
Acute Renal Failure During Hospitalization
Time Frame: During Hospitalization-average 5 days
Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)
During Hospitalization-average 5 days
Hospital Mortality
Time Frame: During Hospitalization-average 5 days
Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.
During Hospitalization-average 5 days
Fasting BG Concentration
Time Frame: During Hospitalization (average 5 days) and outpatient up to 12 weeks
Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups)
During Hospitalization (average 5 days) and outpatient up to 12 weeks
Subjects With Wound and Other Infections
Time Frame: During Hospitalization and outpatient up to 12 weeks
Subjects with wound and other infections.
During Hospitalization and outpatient up to 12 weeks
HbA1c Level
Time Frame: Admission to the hospital and 12-week follow-up outpatient visit
HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).
Admission to the hospital and 12-week follow-up outpatient visit
Hypoglycemia < 40 mg/dl
Time Frame: Inpatient and up to 12 weeks outpatient
Subjects with Hypoglycemia < 40 mg/dl
Inpatient and up to 12 weeks outpatient
Emergency Room Visits
Time Frame: 3 months after discharge
Number of ER visits ONLY for outpatient arms 3,4, and 5.
3 months after discharge
Subjects With Surgical Reinterventions
Time Frame: Inpatient and up to 12 weeks outpatient
Subjects with surgical re-interventions.
Inpatient and up to 12 weeks outpatient
Outpatient Mortality
Time Frame: 3 months after discharge
Deaths among patients after hospital discharge.
3 months after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emory University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boston Medical Center
Rush University
University of Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00066548

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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