Safety and Efficiency of Linagliptin (Trajenta) in the Setting of Internal Medicine Department

Safety and Efficacy of Linagliptin Therapy in the Setting of Internal Medicine Department Type 2 Diabetes Mellitus

Prospective, open labels, randomized study. A total of 60 admitted patient between 18 and 85 years old with known with history of DM for more than 3 months and an average of two consecutive blood glucose levels above 180 mg/dl (after stopping all previous oral antidiabetic and insulin on admission) will be enrolled Patient will be randomized to a 1:1 ratio in two treatment groups regimens- linagliptin (trajenta) once daily combined with basal insulin at bed time (glargine Lantus; sanofi) and basal bolus insulin with glargine once daily and glulisine (Apidra; sanifi) before meals.

Patient will be discharged according to discharged protocol. Follow-up visits will take place at 3 and 6 months post discharged.

Study Overview

• Status: Unknown
• Conditions: DM2
• Intervention / Treatment: Drug: Linagliptin and Basal Insulin; Drug: Basal Insulin and Bolus Insulin

Detailed Description

patient in the linagliptin plus basal insulin will receive linagliptin at single dose of 5 mg/day, and a starting total daily dose (TDD) of glargine of 0.3 units/kg/day, while patients >70 years of age and/or with a serum creatinine >2.0 mg/dL will receive starting TDD of 0.15 units/kg.

Patient in the basal bolus group will start at a TDD of 0.5 units/kg divided half as insulin glargine once daily and half as insulin glulisine before meals. In patients >70 years of age and/or with a serum creatinine >2.0 mg/dL, the starting TDD will be reduce to 0.3 units/kg.

The results of BG values will be measured as 2 hour pre meal glucose, bedtime glucose, and mean daily BG after first day at hospital, HbA1c will be measured on the first day of hospitalization.

Patient with pre-meal and bed time blood glucose levels over 180 mg/dl will receive correctional doses of short acting insulin based on glucose levels as follow- 180-250mg/dl 2 units of insulin, 250-300 mg/dl 3 units of insulin, 350-400 4 units of insulin.

Hypoglycemic events shall be documented as well. In case of treatment failure, defined as average blood glucose levels or two consecutive measurements of more than 240 mg/dl, patient's treatment will be changed to basal based regimen.Patient with pre-meal and bed time blood glucose levels over 180 mg/dl will receive correctional doses of short acting insulin based on glucose levels as follow- 180-250mg/dl 2 units of insulin, 250-300 mg/dl 3 units of insulin, 350-400 4 units of insulin.

Hypoglycemic events shall be documented as well. In case of treatment failure, defined as average blood glucose levels or two consecutive measurements of more than 240 mg/dl, patient's treatment will be changed to basal based regimen.

Patient will be discharged according to discharged protocol. Follow-up visits will take place at 3 and 6 months post discharged.

Patients will be instructed to measure and record BG levels (pre meal glucose, bedtime glucose, and mean daily BG) during three days before follow-ups visits.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male & female patient with Known history of DM for more than 3 months before randomization.
• Hospital admission due to blood glucose levels ranging between 180-400 mg/dl.
• Average of two consecutive blood glucose levels above 180 mg/dl.
• Age between 18 and 85 years old.
• Home treatment with diet alone, any combination of oral antidiabetic agents, or insulin therapy at daily dose <0.4 units/kg.

Exclusion Criteria:

• BG >400 mg/dl in the period before randomization.
• Prior history of hyperglycemic crises.
• Have hyperglycemia without history of diabetes.
• Patient who expected ICU admission or cardiac surgery.
• A history of pancreatitis, active gallbladder disease, Corticosteroid therapy or hepatic disease.
• Impaired renal function (glomerular filtration rate [GFR] <30 mL/min or serum creatinine ≥3.0 mg/dL).
• History of diabetic ketoacidosis.
• Pregnancy.
• Inability to give informed consent (poor mental status).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Linagliptin and Basal Insulin; linagliptin (trajenta) 5mg once daily combined with basal insulin (glargine Lantus; sanofi) 0.15-0.3 units/kg TDD before bed time.	Drug: Linagliptin and Basal Insulin; Linagliptin and bed time insulin glargine linagliptin (trajenta) once daily combined with bed time basal insulin (glargine Lantus; sanofi) before meals; Other Names: Trajenta (Linagliptin)
ACTIVE_COMPARATOR: Basal Insulin and Bolus Insulin; Basal Insulin (Glargine Lantus; Sanofi) based therapy once daily before bedtime and glulisine (Apidra; sanofi) before meals. insulin dose will be 0.5 units/kg divided half as insulin glargine once daily and half as insulin glulisine before meals.	Drug: Basal Insulin and Bolus Insulin; Basal bolus insulin regimen and insulin based therapy with glargine once daily before bedtime and glulisine (Apidra; sanofi) before meals; Other Names: glargine; glulisine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patient with mean blood glucose levels	between 80-180 mg/dl.	After firts day from admission and Up to 14 days, 3 and 6 month after discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in BG values within range	140-180 mg/dl.	After firts day from admission and Up to 14 days, 3 and 6 month after discharge
Number of hypoglycemic events (BG <70 and or < 40 mg/dL).	<70 and or < 40 mg/dL	After firts day from admission and Up to 14 days, 3 and 6 month after discharge
Number of episodes of hyperglycemia	>240 mg/dL	After firts day from admission and Up to 14 days, 3 and 6 month after discharge
TTD (total daily dose) of insulin	units of insulin	After firts day from admission and Up to 14 days, 3 and 6 month after discharge

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2017
• Primary Completion (ANTICIPATED): November 1, 2018
• Study Completion (ANTICIPATED): November 1, 2019

Study Registration Dates

• First Submitted: January 15, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (ACTUAL): February 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Insulin; Insulin, Globin Zinc; Linagliptin
• Other Study ID Numbers: 0643-14RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No