]>
IRCT20080902001181N3 IRCT 2021-03-08 Esfahan University of Medical Sciences The effect of sitagliptin on total daily insulin dose, glycemic index and hypoglycemic attacks The effect of sitagliptin on total daily insulin dose, glycemic index, and hypoglycemic attacks in patients with type 1 diabetes 2021-03-20 anticipated 90 Complete https://irct.ir/trial/54363 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: En In this study, 90 eligible couples will be simple randomly selected. Then random numbers are created by computer software "Random Allocation" and are automatically divided into two parts. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to a patient and therefore they will be randomly assigned to one of the two study groups, Blinding description: In this study, two drugs "sitagliptin " and "placebo" were prepared by a pharmacist with similar shape, color, smell and placed in coded packages, and provided to the researcher. He/She also provides it to the patient without knowing the type of each drug. Also, the patient, the person recording the patient's clinical information, and the statistical analyst will not be aware of the type of intervention. 3 Type 1 diabetes mellitus. Intervention 1: Control group: Patients in this group will receive placebo in two doses of 50 mg daily for three months. Intervention 2: Intervention group: Patients in this group will receive 100 mg of cytagliptin in two doses of 50 mg daily for three months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mansour Siavash
Department of Internal Medicine(Endocrinology), Center for Endocrinology and Metabolism, Khorram Street.
Isfahan Iran (Islamic Republic of) 8187698191 +98 31 3335 9933 siavash@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mansour Siavash
Department of Internal Medicine(Endocrinology), Endocrine and Metabolism Research Center, Khorram Street.
Isfahan Iran (Islamic Republic of) 8187698191 +98 31 3335 9933 siavash@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Having type 1 diabetes treated with insulin, which takes less than 5 years to diagnose. Kidney failure (GFR> 50) Age range between 18 and 60 years Consent to participate in the study 18 years 60 years Both Pregnancy Having a history of sitagliptin sensitivity Having a history of sitagliptin use in the last 6 months Body mass index (BMI) less than 18 kg/m2 E10.9 Type 1 diabetes mellitus without complications Placebo Treatment - Drugs Control group: Patients in this group will receive placebo in two doses of 50 mg daily for three months. Intervention group: Patients in this group will receive 100 mg of cytagliptin in two doses of 50 mg daily for three months. Daily insulin dose. Timepoint: Before and after the intervention. Method of measurement: Daily registration. Blood sugar. Timepoint: Before and after the intervention. Method of measurement: Using a glucometer device. Hypoglycemic attacks. Timepoint: Before and after the intervention. Method of measurement: Number of occurrences (view). Isfahan University of Medical Sciences Approved 2021-01-22 Ethics committee of Isfahan University of Medical Sciences Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq Isfahan Isfehan Iran (Islamic Republic of)