Clinical trial NCT02004366: Linagliptin Inpatient Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Diabetes
Linagliptin
hospital hyperglycemia
inpatient diabetes
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Boston Medical Center
name: Rush University
name: University of Denver
First posted: 2013-12-09
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Differences in Glycemic Control
timeFrame: Inpatient (average 5 days) and outpatient up to 12 weeks
Secondary outcomes:
measure: Hypoglycemia <70 mg/dl
timeFrame: Inpatient (average 5 days) and outpatient up to 12 weeks
measure: Hyperglycemia
timeFrame: Inpatient (average 5 days) and outpatient up to 12 weeks
measure: Daily Dose of Insulin
timeFrame: Inpatient (average 5 days) and outpatient up to 12 weeks
measure: Length of Hospital Stay
timeFrame: During Hospitalization
measure: Number of Participants Requiring ICU Care During Hospitalization
timeFrame: During Hospitalization-average 5 days
measure: Hospital Complications
timeFrame: During Hospitalization-average 5 days
measure: Acute Renal Failure During Hospitalization
timeFrame: During Hospitalization-average 5 days
measure: Hospital Mortality
timeFrame: During Hospitalization-average 5 days
measure: Fasting BG Concentration
timeFrame: During Hospitalization (average 5 days) and outpatient up to 12 weeks
measure: Subjects With Wound and Other Infections
timeFrame: During Hospitalization and outpatient up to 12 weeks
measure: HbA1c Level
timeFrame: Admission to the hospital and 12-week follow-up outpatient visit
measure: Hypoglycemia < 40 mg/dl
timeFrame: Inpatient and up to 12 weeks outpatient
measure: Emergency Room Visits
timeFrame: 3 months after discharge
measure: Subjects With Surgical Reinterventions
timeFrame: Inpatient and up to 12 weeks outpatient
measure: Outpatient Mortality
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado
state: Colorado
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Emory University SOM
name: Guillermo E Umpierrez, MD
role: PRINCIPAL_INVESTIGATOR
References: