This is a clinical trial study, including 45 diabetes mellitus patients, having a history of this disease treated with one of the sulfonylureas but without effect. The patients will be divided two groups.
One group will be treated with insulin and sulforylurea (insulin will be started with dose of 0/2 U/Kg/day and sulfonylurea with previous dose that patient take it) and other group will be treated with insulin alone (with dose of 0/3 U/kg/day). Then the dosage of insulin will be adjusted on the basis of blood glucose levels, and results of blood glucose levels and dosage of the insulin will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204229536N1
Registration date:2012-04-30, 1391/02/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-30, 1391/02/11
Registrant information
Name
Saeedeh Pourmohammad
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1336 0084
Email address
spourmohammad@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qazvin University of Medical Sciences
Expected recruitment start date
2012-03-21, 1391/01/02
Expected recruitment end date
2012-09-19, 1391/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison glycemic control in two group patient treated with insulin alone and insulin plus sulfunyl urea
Public title
The comparison glycemic control in two group patient treated with insulin alone and insulin plus sulfunyl urea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of diabetes mellitus; secondary failure ( HbA1C>7.5 FBS>140 ) and treating with sulfonylurea.
Exclusion criteria: sever heart failure; renal failure ( cr>2.5); artherial failure; take corticosteroide; Diabetic ketoacidosis; liver failure; hypotension and critical illness.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences Ethic Committee
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
Postal code
Approval date
2011-04-27, 1390/02/07
Ethics committee reference number
28/20/4416
Health conditions studied
1
Description of health condition studied
Type II Diabetes
ICD-10 code
E11
ICD-10 code description
Type II Diabetes
Primary outcomes
1
Description
Blood glucose
Timepoint
4 times a day
Method of measurement
Glucometer
2
Description
Weight gain
Timepoint
3 months after intervention
Method of measurement
Digital scale
3
Description
Hypoglycemic event
Timepoint
3 months after intervention
Method of measurement
Glucometer
Secondary outcomes
1
Description
Dosage of the insulin
Timepoint
4 times a day
Method of measurement
With insulin syringes
Intervention groups
1
Description
Intervention group 1: Insulin 0.2 u/kg /day and sulfonylurea whit previous dose
Category
Treatment - Drugs
2
Description
Intervention group 2: Insulin 0.3 u/kg /day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Internal Sector of Booali Hospital
Full name of responsible person
Saeedeh Pourmohammad
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Saeed Assefzadeh
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Shahid Bahonar blvd
City
Qazvin
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, Qazvin 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
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Saeedeh pourmohammad
Position
Assistant of Internal Medicine
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
spourmohammad@qums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Saeedeh Pourmohammad
Position
Assistant of Internal Medicine
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
spourmohammad@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Metabolic Diseases Research Center, Qazvin University of Medical Sciences
Full name of responsible person
Saeedeh Pourmohammad
Position
Assistant of Internal Medicine
Other areas of specialty/work
Street address
Qazvin Metabolic Disease Research Center, Boo-Ali Hospital, Boo-Ali St., Qazvin, Iran
City
Qazvin
Postal code
Phone
+98 28 1336 0084
Fax
Email
spourmohammad@qums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)