Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 35 for:    "Hyperglycemia" | "Insulin Aspart"

Linagliptin Inpatient Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02004366
Recruitment Status : Completed
First Posted : December 9, 2013
Results First Posted : October 30, 2018
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
Boston Medical Center
Rush University
University of Denver
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Linagliptin Drug: Basal Bolus Drug: Linagliptin + 50% Glargine dose on discharge Drug: Linagliptin + 80% Glargine Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Linagliptin

Arm Intervention/treatment
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 Name: Tradjenta

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 Name: 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
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 Name: 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 Name: 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 Name: Trajenta, Lantus




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hypoglycemia <70 mg/dl [ Time Frame: Inpatient (average 5 days) and outpatient up to 12 weeks ]
    Subjects with Hypoglycemia <70 mg/dl

  2. Hyperglycemia [ Time Frame: Inpatient (average 5 days) and outpatient up to 12 weeks ]
    Subjects with BG > 300 mg/dl

  3. Daily Dose of Insulin [ Time Frame: Inpatient (average 5 days) and outpatient up to 12 weeks ]
    Total daily dose of insulin

  4. Length of Hospital Stay [ Time Frame: During Hospitalization ]
    Length of hospital stay (ONLY for inpatient arms 1 and 2)

  5. 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

  6. Hospital Complications [ Time Frame: During Hospitalization-average 5 days ]
    Subjects with composite complication (ONLY for inpatient arms 1 and 2)

  7. Acute Renal Failure During Hospitalization [ Time Frame: During Hospitalization-average 5 days ]
    Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)

  8. Hospital Mortality [ Time Frame: During Hospitalization-average 5 days ]
    Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.

  9. 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)

  10. Subjects With Wound and Other Infections [ Time Frame: During Hospitalization and outpatient up to 12 weeks ]
    Subjects with wound and other infections.

  11. 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).

  12. Hypoglycemia < 40 mg/dl [ Time Frame: Inpatient and up to 12 weeks outpatient ]
    Subjects with Hypoglycemia < 40 mg/dl

  13. Emergency Room Visits [ Time Frame: 3 months after discharge ]
    Number of ER visits ONLY for outpatient arms 3,4, and 5.

  14. Subjects With Surgical Reinterventions [ Time Frame: Inpatient and up to 12 weeks outpatient ]
    Subjects with surgical re-interventions.

  15. Outpatient Mortality [ Time Frame: 3 months after discharge ]
    Deaths among patients after hospital discharge.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004366


Locations
Layout table for location information
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80220
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Grady Memorial Hospital
Atlanta, Georgia, United States
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Emory University
Boston Medical Center
Rush University
University of Denver
Investigators
Layout table for investigator information
Principal Investigator: Guillermo E Umpierrez, MD Emory University SOM
  Study Documents (Full-Text)

Documents provided by Guillermo Umpierrez, MD, Emory University:

Layout table for additonal information
Responsible Party: Guillermo Umpierrez, MD, Professor of Medicine, Emory University
ClinicalTrials.gov Identifier: NCT02004366     History of Changes
Other Study ID Numbers: IRB00066548
First Posted: December 9, 2013    Key Record Dates
Results First Posted: October 30, 2018
Last Update Posted: February 20, 2019
Last Verified: February 2019
Keywords provided by Guillermo Umpierrez, MD, Emory University:
Diabetes
Linagliptin
hospital hyperglycemia
inpatient diabetes
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Aspart
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Insulin Glargine
Insulin Lispro
Linagliptin
Insulin, Short-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action