The aim of our study is to compare the therapeutic effect of pioglitasion and sitagliptin in blood sugar reduction in patients with uncontrolled type 2 diabetes undergoing Metformin treatment ; as a clinical study.According to the including criteria new cases of diabetes with the age of 30-60 years who have the HbA1C between 8-9.5% and BMI between 25 to 35 during the one past year entered our experiment. The predicted volume is 160 patients and are referred to the endocrinology clinic in Vali Asr hospital .The following items were checked in the beginning and at the 3rd month of treatment: HbA1C, TG, Chol, HDL, FBS,Bs 2hpp are analyzed in the laboratory and Blood Pressure, Body Weight will be recorded. . Our patients were randomly divided into two groups{random allocation}. The first group undergoing treatment with Metformin 1 to 2 gr daily and Pioglitasione 15 to 30mg daily, the other group undergoing treatment with Metformin 1 to2 gr daily and sitagliptin 100 to 50mg daily. All the patients were consulted by a nutritionist for the diabetic regimen. Patients were checked monthly to see if the treatment regimen were taken properly and in the case of exclusion criteria in the study will not be.(gastrointestinal and eye and kidney complications).in this study;reduction of HbA1C and FBS and Bs 2hpp as the primary outcome and improvement of lipid profiles and weight loss as a secondary outcome are discussed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061619554N4
Registration date:2017-02-07, 1395/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-07, 1395/11/19
Registrant information
Name
Maryam Jameshorani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00989126416972 و 00982433770805
Email address
dr.shirinjameshorani@zumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research; Zanjan University of Medical Sciences
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Efficacy and Safety of Sitagliptin with Pioglitazon in patients with uncontrolled type 2 diabetes on metformin
Public title
Sitagliptin and Pioglitazon effects in the treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Newly diagnosed type 2 diabetic patients In the past year ; HBA1C between 8 to 9.5; BMI between 35-25; Lack of insulin; written consent to participate in the study criteria ;
Exclusion criteria: Liver problems (abnormal level of liver enzymes) (more than 1.5 times the normal); renal failure (BUN and CR abnormal) (creatinine increase greater than1.5); digestive problems (including dyspepsia, diarrhea, vomiting); acidosis (ie, ABG : PH <7/35) heart failure with EF below 35% ; macular edema eye
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Zanjan university of medical sciences ;karmandan street;zanjan