Back to resultsLinagliptin Inpatient Trial
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Linagliptin
Basal Bolus
Linagliptin
Linagliptin + 50% Glargine dose on discharge
Linagliptin + 80% Glargine
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Linagliptin, hospital hyperglycemia, inpatient diabetes
Eligibility Criteria
Inclusion Criteria:
- Males or female surgical non-ICU patients ages between18 and 80 years
- 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.
- 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:
- Age < 18 or > 80 years.
- Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
- 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).
- Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
- Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
- Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
- Patients with clinically relevant pancreatic or gallbladder disease.
- Patients with previous history of pancreatitis
- Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).
- Chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Pregnancy or breast feeding at time of enrollment into the study.
- Patients who received supplemental sliding scale insulin >72 hours prior to randomization
- Patients who received basal insulin > 48 hours prior to randomization
Sites / Locations
- University of Colorado
- Emory University Hospital
- Grady Memorial Hospital
- Rush University Medical Center
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Linagliptin In-hospital
Basal Bolus In-hospital
Linagliptin on discharge
Linagliptin+50%Glargine dose on d/c
Linagliptin+80%Glargine dose on d/c
Arm Description
Linagliptin once daily+ correction doses of aspart or lispro if needed
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
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.
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.
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.
Outcomes
Primary Outcome Measures
Differences in Glycemic Control
Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
Secondary Outcome Measures
Hypoglycemia <70 mg/dl
Subjects with Hypoglycemia <70 mg/dl
Hyperglycemia
Subjects with BG > 300 mg/dl
Daily Dose of Insulin
Total daily dose of insulin
Length of Hospital Stay
Length of hospital stay (ONLY for inpatient arms 1 and 2)
Number of Participants Requiring ICU Care During Hospitalization
Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization
Hospital Complications
Subjects with composite complication (ONLY for inpatient arms 1 and 2)
Acute Renal Failure During Hospitalization
Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)
Hospital Mortality
Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.
Fasting BG Concentration
Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups)
Subjects With Wound and Other Infections
Subjects with wound and other infections.
HbA1c Level
HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).
Hypoglycemia < 40 mg/dl
Subjects with Hypoglycemia < 40 mg/dl
Emergency Room Visits
Number of ER visits ONLY for outpatient arms 3,4, and 5.
Subjects With Surgical Reinterventions
Subjects with surgical re-interventions.
Outpatient Mortality
Deaths among patients after hospital discharge.
Full Information
NCT ID
NCT02004366
First Posted
November 19, 2013
Last Updated
February 18, 2019
Sponsor
Emory University
Collaborators
Boston Medical Center, Rush University, University of Denver
1. Study Identification
Unique Protocol Identification Number
NCT02004366
Brief Title
Linagliptin Inpatient Trial
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 Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Boston Medical Center, Rush University, University of Denver
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Linagliptin, hospital hyperglycemia, inpatient diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Linagliptin In-hospital
Arm Type
Experimental
Arm Description
Linagliptin once daily+ correction doses of aspart or lispro if needed
Arm Title
Basal Bolus In-hospital
Arm Type
Active Comparator
Arm Description
Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed
Arm Title
Linagliptin on discharge
Arm Type
Experimental
Arm Description
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.
Arm Title
Linagliptin+50%Glargine dose on d/c
Arm Type
Experimental
Arm Description
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.
Arm Title
Linagliptin+80%Glargine dose on d/c
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Other Intervention Name(s)
Tradjenta
Intervention Description
Linagliptin once daily + correction doses of rapid acting insulin if needed
Intervention Type
Drug
Intervention Name(s)
Basal Bolus
Other Intervention Name(s)
Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)
Intervention Description
Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed
Intervention Type
Drug
Intervention Name(s)
Linagliptin
Other Intervention Name(s)
Trajenta
Intervention Description
Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.
Intervention Type
Drug
Intervention Name(s)
Linagliptin + 50% Glargine dose on discharge
Other Intervention Name(s)
Trajenta, Lantus
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Linagliptin + 80% Glargine
Other Intervention Name(s)
Trajenta, Lantus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Differences in Glycemic Control
Description
Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.
Time Frame
Inpatient (average 5 days) and outpatient up to 12 weeks
Secondary Outcome Measure Information:
Title
Hypoglycemia <70 mg/dl
Description
Subjects with Hypoglycemia <70 mg/dl
Time Frame
Inpatient (average 5 days) and outpatient up to 12 weeks
Title
Hyperglycemia
Description
Subjects with BG > 300 mg/dl
Time Frame
Inpatient (average 5 days) and outpatient up to 12 weeks
Title
Daily Dose of Insulin
Description
Total daily dose of insulin
Time Frame
Inpatient (average 5 days) and outpatient up to 12 weeks
Title
Length of Hospital Stay
Description
Length of hospital stay (ONLY for inpatient arms 1 and 2)
Time Frame
During Hospitalization
Title
Number of Participants Requiring ICU Care During Hospitalization
Description
Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization
Time Frame
During Hospitalization-average 5 days
Title
Hospital Complications
Description
Subjects with composite complication (ONLY for inpatient arms 1 and 2)
Time Frame
During Hospitalization-average 5 days
Title
Acute Renal Failure During Hospitalization
Description
Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)
Time Frame
During Hospitalization-average 5 days
Title
Hospital Mortality
Description
Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.
Time Frame
During Hospitalization-average 5 days
Title
Fasting BG Concentration
Description
Average - per hospital stay - fasting BG concentration (for in-hospital groups), and average - per outpatient follow-up period - fasting BG concentration (for discharge groups)
Time Frame
During Hospitalization (average 5 days) and outpatient up to 12 weeks
Title
Subjects With Wound and Other Infections
Description
Subjects with wound and other infections.
Time Frame
During Hospitalization and outpatient up to 12 weeks
Title
HbA1c Level
Description
HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).
Time Frame
Admission to the hospital and 12-week follow-up outpatient visit
Title
Hypoglycemia < 40 mg/dl
Description
Subjects with Hypoglycemia < 40 mg/dl
Time Frame
Inpatient and up to 12 weeks outpatient
Title
Emergency Room Visits
Description
Number of ER visits ONLY for outpatient arms 3,4, and 5.
Time Frame
3 months after discharge
Title
Subjects With Surgical Reinterventions
Description
Subjects with surgical re-interventions.
Time Frame
Inpatient and up to 12 weeks outpatient
Title
Outpatient Mortality
Description
Deaths among patients after hospital discharge.
Time Frame
3 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males or female surgical non-ICU patients ages between18 and 80 years
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.
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:
Age < 18 or > 80 years.
Subjects with increased BG concentration, but without a history of diabetes (stress hyperglycemia).
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).
Treatment with dipeptidyl peptidase-4 (DPP4) inhibitor or Glucagon-like peptide-1 (GLP1) analogs during the past 3 months prior to admission.
Acute critical illness or coronary artery bypass graft (CABG) surgery expected to require admission to a critical care unit.
Subjects with gastrointestinal obstruction or adynamic ileus or those expected to require gastrointestinal suction.
Patients with clinically relevant pancreatic or gallbladder disease.
Patients with previous history of pancreatitis
Patients with acute myocardial infarction, clinically significant hepatic disease or significantly impaired renal function (GFR < 30 ml/min).
Chronic use of steroid with total daily dose (prednisone equivalent) >5 mg/day
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Pregnancy or breast feeding at time of enrollment into the study.
Patients who received supplemental sliding scale insulin >72 hours prior to randomization
Patients who received basal insulin > 48 hours prior to randomization
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo E Umpierrez, MD
Organizational Affiliation
Emory University SOM
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Linagliptin Inpatient Trial
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