Efficacy and safety of initial combination therapy with gemigliptin and metformin compared with monotherapy with either drug in patients with type 2 diabetes: A double-blind randomized controlled trial (INICOM study)

G Life Sciences0 sites433 target enrollmentDecember 13, 2019

Overview

No summary available.

Registry

who.int

Start Date

December 13, 2019

End Date

January 3, 2015

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

G Life Sciences

•1\. Patients with type 2 diabetes mellitus
•2\. Adults over 20 of age
•3\. Patients with hemoglobin A1c (HbA1c) over 7\.5% at Visit1(screening) and no previous antidiabetic drugs before Visit 1(screening) or patients with hemoglobin A1c (HbA1c) between 7%\~10\.5%, Patients treated with metformin monotherapy before Visit 1(screening).
•Patients with no previous antidiabetic drugs
•4\. Patients with hemoglobin A1c (HbA1c) between 7\.5%\~11% at Visit 2(randomization)

•1\. Patients with type 1 diabetes mellitus Diabetic ketoacidosis or Hyperosmolar non\-ketotic coma.
•2\. Patients with gestational diabetes, or secondary diabetes
•3\. Patients with New York Heart Association (NYHA) class III\-IV congestive heart failure or patients with arrhythmia requiring treatment
•4\. Patients with dysfunctional thyroid gland (with abnormal level of TSH)
•5\. Patients with active bladder cancer.
•6\. Tests which need to be given radiation iodide dye by intravenous.(ex, intravenous urography, intravenous cholangiography, angiography, CT with dye)
•7\. Severe infection, pre or post operation.(Simple surgery which does not have restriction of food and fluid), severe trauma patient.
•8\. Patients with pituitary insufficiency or adrenal dysfunction.
•9\. Patients with pulmonary infarction, severe pulmonary dysfunction, hypoxemia.
•10\. Patients with gastrointestinal disorders(ex. Dehydration, Diarrhea, Vomiting)