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

NCT ID: NCT03051243

Last Updated: 2017-09-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2019-11-01

Brief Summary

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.

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.

Conditions

DM2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Linagliptin and Basal Insulin

Intervention Type: DRUG

Linagliptin and bed time insulin glargine linagliptin (trajenta) once daily combined with bed time basal insulin (glargine Lantus; sanofi) before meals

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.

Group Type: ACTIVE_COMPARATOR

Basal Insulin and Bolus Insulin

Intervention Type: DRUG

Basal bolus insulin regimen and insulin based therapy with glargine once daily before bedtime and glulisine (Apidra; sanofi) before meals

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Trajenta (Linagliptin); glargine; glulisine

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dror Dicker

Head of internal medicine D' and obesity clinic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

0643-14RMC

Identifier Type: -

Identifier Source: org_study_id