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IRCT20170513033941N66 IRCT 2019-10-28 Kashan University of Medical Sciences Comparison of pioglitazone and linagliptin Comparison of the effects of pioglitazone and linagliptin on glycemic control, lipid profile, and hs-CRP in patients with type 2 diabetes mellitus under treatment with metformin 2019-09-23 anticipated 60 Complete https://irct.ir/trial/42488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned into two groups. A randomization list will be generated from 1 to 60 by a random number generator (https://stattrek.com/statistics/random-number-generator.aspx) and patients were randomly assigned into each intervention group by their numbers. The block randomization technique (including AABB, BBAA, ABAB BABA, ABBA, BAAB) with 1:1 ratio will be used to achieve balanced group sizes. Drugs and placebos are in the same packaging at the Pharmaceutical company. Only the code is written on the packages. Patients and researchers do not know the type of drug and after analyzing the data, packet codes are decoded, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Beheshti clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of drugs. 3 Type 2 diabetes mellitus. Intervention 1: Intervention group1: 30 mg pioglitazone (osveh pharmaceutical company, Tehran, Iran) daily, for 3 months orally. Intervention 2: Intervention group2: 5 mg linagliptin (Alhavi pharmaceutical company, Tehran, Iran) daily, for 3 months orally. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Dr. Shadi yazdani
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5546 3378 Dr.yazdani.shadi@gmail.com Kashan University of Medical Sciences scientific Dr. Batol Zamani
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8115187159 +98 31 5554 2999 batol_zamani2007@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients diagnosed with type 2 diabetes Individuals aged 30-50 years old FBS ≥140 under treatment with metformin for at least 3 months 30 years 50 years Both Secondary diabetes due to cushing syndrome, acromegaly and other diseases systemic inflammatory diseases such as rheumatoid arthritis, IBD, vasculitis, etc. renal or liver or heart failure malignancy under insulin therapy pregnancy unwillingness to cooperate E11 Type 2 diabetes mellitus Treatment - Drugs Treatment - Drugs Intervention group1: 30 mg pioglitazone (osveh pharmaceutical company, Tehran, Iran) daily, for 3 months orally. Intervention group2: 5 mg linagliptin (Alhavi pharmaceutical company, Tehran, Iran) daily, for 3 months orally. Fasting blood glucose levels. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: Enzymatic kit. HbA1c. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: HPLC. Total cholesterol. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: Enzymatic kit. High-density lipoprotein (HDL) cholesterol. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: Enzymatic kit. Low-density lipoprotein (LDL) cholesterol. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: Enzymatic kit. High-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: Elisa kit. Weight. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: scale. Systolic and diastolic blood pressure. Timepoint: At the beginning of the study and after 3 months of intervention. Method of measurement: sphygmomanometer. Kashan University of Medical Sciences Approved 2019-05-06 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)