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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


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 events

episodes 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


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.


Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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