Objective: Comparison of pioglitazone with sitagliptin effect on glycemic state in patients with uncontrolled diabetes 2 using metformin and sulfonylureas
Study design: Random block
Study population: In this study, patients with uncontrolled type 2 diabetes treated with metformin and sulfonylureas presented to endocrine clinic of Shahid Rahimi hospital of Khorramabad from October 2016 to October 2017 will be considered.
Inclusion criteria:
patients with type 2 diabetes who are older than 18 years treated with 1500 mg metformin and 10-20mg sulfonylureas per day are included in the study. These patients should have HbA1c greater than 7, and fasting glucose greater than 126 mg / dL.
Exclusion criteria
1. patients who have type 1 diabetes,
2. known case of heart disease and exertional dyspnea grade 3 and 4
3. kidney disease (GFR <30)
4. ALT / AST more than 3 times normal
Sample size: 60
intervention or interventions studied:
Group 1 : sitagliptin 50 mg plus metformin 1500 mg and sulfonylurea 10-20mg per day
Group 2: pioglitazone 30 mg plus metformin 1500 mg and sulfonylurea 10-20mg per day
intervention: 18.06.2016 to 19.06.2017
primary outcome: FPG, HbA1c, insulin, HOMA index, weight, HDL, TG, LDL, blood pressure
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112631104N1
Registration date:2017-01-14, 1395/10/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-14, 1395/10/25
Registrant information
Name
Habib Moazami Goodarzi
Name of organization / entity
Lorestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3333 6143
Email address
dr.goudarzi.h@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University Of Medical Sciences
Expected recruitment start date
2016-06-18, 1395/03/29
Expected recruitment end date
2017-06-19, 1396/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pioglitazone with sitagliptin effect on glycemic state in patients with uncontrolled diabetes 2 using metformin and sulfonylureas
Public title
Comparison of pioglitazone with sitagliptin effect in diabetes melitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with type 2 diabetes who are older than 18 years treated with 1500 mg metformin and 10-20mg sulfonylureas per day are included in the study. These patients should have HbA1c greater than 7 and fasting glucose greater than 126 mg / dL.
Exclusion criteria:
1) patients who have type 1 diabetes,
2) known case of heart disease and exertional dyspnea, grade 3 and 4
3) kidney disease (GFR <30),
4) ALT / AST more than 3 times normal
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University Of Medical Sciences