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

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ClinicalTrials.gov Identifier: NCT03051243
Recruitment Status : Unknown
Verified September 2017 by Dror Dicker, Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 13, 2017
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Dror Dicker, Rabin Medical Center

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.


Condition or disease Intervention/treatment Phase
DM2 Drug: Linagliptin and Basal Insulin Drug: Basal Insulin and Bolus Insulin Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Linagliptin Therapy in the Setting of Internal Medicine Department Type 2 Diabetes Mellitus
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2019


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 Name: 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




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


Secondary Outcome Measures :
  1. Difference in BG values within range [ Time Frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge ]
    140-180 mg/dl.

  2. Number of hypoglycemic events (BG <70 and or < 40 mg/dL). [ Time Frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge ]
    <70 and or < 40 mg/dL

  3. Number of episodes of hyperglycemia [ Time Frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge ]
    >240 mg/dL

  4. TTD (total daily dose) of insulin [ Time Frame: After firts day from admission and Up to 14 days, 3 and 6 month after discharge ]
    units of insulin



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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Responsible Party: Dror Dicker, Head of internal medicine D' and obesity clinic, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03051243    
Other Study ID Numbers: 0643-14RMC
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Linagliptin
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action