Linagliptin Inpatient Trial

Phase 4CompletedNCT02004366

Emory University295 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

295

Interventions

LinagliptinDRUG

Linagliptin once daily + correction doses of rapid acting insulin if needed

Basal BolusDRUG

Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed

LinagliptinDRUG

Patients with admission A1C \< 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.

Linagliptin + 50% Glargine dose on dischargeDRUG

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.

Linagliptin + 80% GlargineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (5)

University of Colorado

Denver, Colorado, United States

Emory University Hospital

Atlanta, Georgia, United States

Grady Memorial Hospital

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

Boston Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Differences in Glycemic Control

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 Outcomes

Hypoglycemia <70 mg/dl

Subjects with Hypoglycemia \<70 mg/dl

Time frame: Inpatient (average 5 days) and outpatient up to 12 weeks

Hyperglycemia

Subjects with BG \> 300 mg/dl

Time frame: Inpatient (average 5 days) and outpatient up to 12 weeks

Daily Dose of Insulin

Total daily dose of insulin

Time frame: Inpatient (average 5 days) and outpatient up to 12 weeks

Length of Hospital Stay

Length of hospital stay (ONLY for inpatient arms 1 and 2)

Time frame: During Hospitalization

Number of Participants Requiring ICU Care During Hospitalization

Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization

Time frame: During Hospitalization-average 5 days

Hospital Complications

Subjects with composite complication (ONLY for inpatient arms 1 and 2)

Time frame: During Hospitalization-average 5 days

Acute Renal Failure During Hospitalization

Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)

Time frame: During Hospitalization-average 5 days

Hospital Mortality

Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.

Time frame: During Hospitalization-average 5 days

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)

Time frame: During Hospitalization (average 5 days) and outpatient up to 12 weeks

Subjects With Wound and Other Infections

Subjects with wound and other infections.

Time frame: During Hospitalization and outpatient up to 12 weeks

HbA1c Level

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

Hypoglycemia < 40 mg/dl

Subjects with Hypoglycemia \< 40 mg/dl

Time frame: Inpatient and up to 12 weeks outpatient

Emergency Room Visits

Number of ER visits ONLY for outpatient arms 3,4, and 5.

Time frame: 3 months after discharge

Subjects With Surgical Reinterventions

Subjects with surgical re-interventions.

Time frame: Inpatient and up to 12 weeks outpatient

Outpatient Mortality

Deaths among patients after hospital discharge.

Time frame: 3 months after discharge

Linagliptin Inpatient Trial

Overview

Conditions

Interventions

Eligibility

Locations (5)

Outcomes

Primary Outcomes

Secondary Outcomes