Linagliptin Inpatient Trial
Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Linagliptin (Drug); Basal Bolus (Drug); Linagliptin (Drug); Linagliptin + 50% Glargine dose on discharge (Drug); Linagliptin + 80% Glargine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Emory University Official(s) and/or principal investigator(s): Guillermo E Umpierrez, MD, Principal Investigator, Affiliation: Emory University SOM
Overall contact: Guillermo E Umpierrez, MD, Phone: 404-778-1665
Summary
A total of 280 patients with type 2 diabetes (T2DM) who have undergone surgical procedure
will be enrolled in the study. These patients could be on diet, oral hypoglycemia medication
or low dose insulin prior to their admission.
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Differences in glycemic control
Secondary outcome: hypoglycemic eventsepisodes of hyperglycemia daily dose of insulin Length of hospital stay ICU Care Hospital complications Acute renal failure Hospital mortality Fasting and postprandial BG concentration hypoglycemic events HbA1c daily dose of insulin emergency room visits Number of complications Linagliptin after discharge
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Guillermo E Umpierrez, MD, Phone: 404-778-1665
University of Colorado, Denver, Colorado 80220, United States; Recruiting Neda Rasouli, MD, Email: neda.rasouli@ucdenver.edu Neda Rasouli, MD, Principal Investigator
Emory University Hospital, Atlanta, Georgia 30322, United States; Recruiting Guillermo Umpierrez, MD, Phone: 404-778-1665 Dawn Smiley, MD, Phone: 404-778-1664
Grady Memorial Hospital, Atlanta, Georgia, United States; Recruiting Guillermo Umpierrez, MD, Email: geumpie@emory.edu Guillermo E Umpierrez, MD, Principal Investigator Priya Vellanki, MD, Sub-Investigator
Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting David Baldwin, MD, Phone: 312-942-6163, Email: David_Baldwin@rush.net David Baldwin, MD, Sub-Investigator
Boston Medical Center, Boston, Massachusetts 02118, United States; Recruiting Sara Alexanian, MD, Phone: 617-414-8040, Email: sara.alexanian@bmc.org Sara Alexanian, MD, Principal Investigator
Additional Information
Starting date: January 2014
Last updated: March 6, 2015
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