Linagliptin Inpatient Trial

Type 2 Diabetes Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004366
• Other study ID #: IRB00066548
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: March 2017

Study information

• Verified date: February 2019
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Linagliptin
Linagliptin once daily + correction doses of rapid acting insulin if needed
• 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
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Boston Medical Center	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Colorado	Denver	Colorado

Sponsors (4)

Lead Sponsor	Collaborator
Emory University	Boston Medical Center, Rush University, University of Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Hypoglycemia <70 mg/dl	Subjects with Hypoglycemia <70 mg/dl	Inpatient (average 5 days) and outpatient up to 12 weeks
Secondary	Hyperglycemia	Subjects with BG > 300 mg/dl	Inpatient (average 5 days) and outpatient up to 12 weeks
Secondary	Daily Dose of Insulin	Total daily dose of insulin	Inpatient (average 5 days) and outpatient up to 12 weeks
Secondary	Length of Hospital Stay	Length of hospital stay (ONLY for inpatient arms 1 and 2)	During Hospitalization
Secondary	Number of Participants Requiring ICU Care During Hospitalization	Need for intensive care unit (ICU) care (transfer to ICU) during hospitalization	During Hospitalization-average 5 days
Secondary	Hospital Complications	Subjects with composite complication (ONLY for inpatient arms 1 and 2)	During Hospitalization-average 5 days
Secondary	Acute Renal Failure During Hospitalization	Subjects with Acute renal failure (ONLY for inpatient arms 1 and 2)	During Hospitalization-average 5 days
Secondary	Hospital Mortality	Hospital mortality (ONLY in-patient). Mortality is defined as death occurring during hospital stay.	During Hospitalization-average 5 days
Secondary	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)	During Hospitalization (average 5 days) and outpatient up to 12 weeks
Secondary	Subjects With Wound and Other Infections	Subjects with wound and other infections.	During Hospitalization and outpatient up to 12 weeks
Secondary	HbA1c Level	HbA1c level at admission (for in-patient arms) and HbA1c level at 12-week follow-up outpatient visit (for discharge arms).	Admission to the hospital and 12-week follow-up outpatient visit
Secondary	Hypoglycemia < 40 mg/dl	Subjects with Hypoglycemia < 40 mg/dl	Inpatient and up to 12 weeks outpatient
Secondary	Emergency Room Visits	Number of ER visits ONLY for outpatient arms 3,4, and 5.	3 months after discharge
Secondary	Subjects With Surgical Reinterventions	Subjects with surgical re-interventions.	Inpatient and up to 12 weeks outpatient
Secondary	Outpatient Mortality	Deaths among patients after hospital discharge.	3 months after discharge