Linagliptin Inpatient Trial

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.

Conditions

• Type 2 Diabetes

Interventions

DRUG

Linagliptin

Linagliptin once daily + correction doses of rapid acting insulin 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

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.

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.

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.

Sponsors & Collaborators

• Boston Medical Center

  collaborator OTHER

• Rush University

  collaborator OTHER

• University of Denver

  collaborator OTHER

• Emory University

  lead OTHER

Principal Investigators

• Guillermo E Umpierrez, MD · Emory University SOM

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-01-31

Primary Completion

2017-02-28

Completion

2017-03-31

Countries

• United States

Study Locations