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

NCT03051243 | Unknown Phase 3 DMC

• 1 other identifier: 0643-14RMC
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

DM2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Difference in BG values within range

  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).

  After firts day from admission and Up to 14 days, 3 and 6 month after discharge

• Number of episodes of hyperglycemia

  After firts day from admission and Up to 14 days, 3 and 6 month after discharge

• TTD (total daily dose) of insulin

  After firts day from admission and Up to 14 days, 3 and 6 month after discharge

Study Arms (2)

Linagliptin and Basal Insulin

ACTIVE COMPARATOR

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

Basal Insulin and Bolus Insulin

ACTIVE COMPARATOR

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

Interventions

Linagliptin and Basal Insulin DRUG

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

Also known as: Trajenta (Linagliptin)

Linagliptin and Basal Insulin

Basal Insulin and Bolus Insulin DRUG

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

Also known as: glargine, glulisine

Basal Insulin and Bolus Insulin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rabin Medical Center: lead

MeSH Terms

Interventions

Linagliptin; Insulin Glargine; insulin glulisine

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of internal medicine D' and obesity clinic

Study Record Dates

• First Submitted: January 15, 2017
• First Posted: February 13, 2017
• Study Start: October 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: September 11, 2017

Record last verified: 2017-09