Linagliptin Inpatient Trial

NCT02004366 | Completed Phase 4 Results DMC

• 1 other identifier: IRB00066548
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 5

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Linagliptin; hospital hyperglycemia; inpatient diabetes

Outcome Measures

Primary Outcomes (1)

• Differences in Glycemic Control

  Determine differences in glycemic control as measured by mean daily BG concentration between linagliptin alone and basal bolus therapy group.

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

Secondary Outcomes (15)

• Hypoglycemia <70 mg/dl

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

• Hyperglycemia

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

• Daily Dose of Insulin

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

• Length of Hospital Stay

  During Hospitalization

• Number of Participants Requiring ICU Care During Hospitalization

  During Hospitalization-average 5 days

Study Arms (5)

Linagliptin In-hospital

EXPERIMENTAL

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

Drug: Linagliptin

Basal Bolus In-hospital

ACTIVE COMPARATOR

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

Drug: Basal Bolus

Linagliptin on discharge

EXPERIMENTAL

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

Linagliptin+50%Glargine dose on d/c

EXPERIMENTAL

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

Linagliptin+80%Glargine dose on d/c

EXPERIMENTAL

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

Interventions

Linagliptin DRUG

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

Also known as: Tradjenta

Linagliptin In-hospital

Basal Bolus 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

Also known as: Glargine (Lantus) + aspart (Novolog) or lispro (Humalog)

Basal Bolus In-hospital

Linagliptin + 50% Glargine dose on discharge 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.

Also known as: Trajenta, Lantus

Linagliptin+50%Glargine dose on d/c

Linagliptin + 80% Glargine 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.

Also known as: Trajenta, Lantus

Linagliptin+80%Glargine dose on d/c

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Boston Medical Center: collaborator
• Rush University: collaborator
• University of Denver: collaborator

Study Sites (5)

University of Colorado

Denver, Colorado, 80220, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Linagliptin; Insulin Glargine; Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting

Results Point of Contact

• Title: Priyathama Vellanki
• Organization: Emory University

priyathama.vellanki@emory.edu

404-778-1665

Study Officials

• Guillermo E Umpierrez, MD

  Emory University SOM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: December 9, 2013
• Study Start: January 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 20, 2019
• Results First Posted: October 30, 2018

Record last verified: 2019-02

Locations

US (5)