Linagliptin Inpatient Trial

NCT ID: NCT02004366

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 295 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-03-31

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Linagliptin In-hospital

Linagliptin once daily+ correction doses of aspart or lispro if needed

Group Type: EXPERIMENTAL

Linagliptin

Intervention Type: DRUG

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

Basal Bolus In-hospital

Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed

Group Type: ACTIVE_COMPARATOR

Basal Bolus

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Linagliptin

Intervention Type: DRUG

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 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.

Group Type: EXPERIMENTAL

Linagliptin + 50% Glargine dose on discharge

Intervention Type: DRUG

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%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.

Group Type: EXPERIMENTAL

Linagliptin + 80% Glargine

Intervention Type: DRUG

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.

Interventions

Linagliptin

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

Intervention Type: 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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Tradjenta; Glargine (Lantus) + aspart (Novolog) or lispro (Humalog); Trajenta; Trajenta, Lantus; Trajenta, Lantus

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: collaborator

Rush University

OTHER

Sponsor Role: collaborator

University of Denver

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Umpierrez, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guillermo E Umpierrez, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University SOM

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00066548

Identifier Type: -

Identifier Source: org_study_id