The aim of this study, which is designed as a clinical test, is to investigate the effect of adding Sitagliptin and Pioglitazone in patients who their Glycemic status can’t be controlled by Metformin and Sulfonylurea. Inclusion criteria:Diabetics Type II; taking complete doze of Metformin (1500-2000mg) and a Sulfonylurea (15-20mg); age range from 30 to 65; 7% ≤ HbAlc, Reluctance to take insulin; willingness to participate in the study and exclusion criteria: pregnant patient; patients with heart failure; patients with renal insufficiency; patients with bladder cancer background; Glycemic severe complications including DKA; Reluctance to participate in the study. Diabetics Type II who take complete doze of Metformin (1500-2000mg per day) and a Sulfonylurea (Glibenclamide 15-20mg per day) and their diabetes hasn’t been controlled will be included in the study. Then they will be divided into two groups of equal numbers randomly. Pioglitazone 30mg will be prescribed for one group and Sitagliptin 100mg for the other group as a third medication. FBS (Fasting Blood Sugar) and HbA1c will be measured before the study and three months after the study. Variables such as age, sex, FBS and HbA1c will be studied. Hereby the effect of these two medications will be compared in term of their effectiveness and side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201704246712N3
Registration date:2017-05-09, 1396/02/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-09, 1396/02/19
Registrant information
Name
Nasser Aghamohammadzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
aghamohammadzadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Tabriz University of Medical Science
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Sitagliptin with Pioglitazone on the Control of Diabetic Patients
Public title
Comparison of the Efficacy of Sitagliptin with Pioglitazone on the Control of Diabetic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diabetics Type II; taking complete doze of Metformin (1500-2000mg) and a Sulfonylurea (15-20mg); age range from 30 to 65; 7% ≤ HbAlc; Reluctance to take insulin; willingness to participate in the study. Exclusion criteria: pregnant patient; patients with heart failure; patients with renal insufficiency; patients with bladder cancer background; Glycemic severe complications including DKA; Reluctance to participate in the study.
Age
From 30 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Tabriz University of Medical Sciences
Street address
Central Bulding of Medical Science University, St. Golgasht, St. Azadi ,Tabriz
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.TBZMED.REC.1395.397
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 2
ICD-10 code
ٍE10-E14
ICD-10 code description
Diabetes mellitus
Primary outcomes
1
Description
Fasting blood sugar
Timepoint
Before treatment and three months after starting the drug
Method of measurement
Test
2
Description
HbA1C
Timepoint
Before treatment and three months after starting the drug
Method of measurement
Test
Secondary outcomes
empty
Intervention groups
1
Description
In the first group Pioglitazone 30 mg daily as the third drug will be used.
Category
Treatment - Drugs
2
Description
In the second group Sytaglyptyn 100 mg daily medicine as the third drug will be used.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences, Imam Reza Hospital
Full name of responsible person
Dr. Nasser Aghamohammadzadeh
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Nasser Aghmohammadzadeh
Position
Endocrinology and Metabolism/ Associate Professor
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41333557850
Fax
Email
nmzmd@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Nasser Aghamohammadzadeh
Position
Endocrinology and Metabolism/Associate Professor
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz university of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
nmzmd@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Servin Dalil
Position
MD, Resident of Internal Medicine
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
00
Fax
Email
Sarvin.Dalil@Gmail.Com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)