Comparing the effect of basal insulin with modified-release gliclazide on glycemic control in type 2 diabetic patients with HbA1C above 10%
Design
An open-label, randomized- clinical trial study with parallel groups and phases 3 on 90 patients. Randomization will be done based on block randomization using Random allocation software.
Settings and conduct
In this study, 90 type 2 diabetic patients with HbA1C above 10% referred to Urmia Imam Khomeini Hospital will be included. Gliclazide-MR 30 mg twice a day in one group and basal insulin 0.1-0.3 u/kg in the other group will be randomly prescribed for three months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: type 2 diabetic patients; with HbA1C above 10%; age over 30 years old. Exclusion criteria: Patients with kidney and liver failure; cardiovascular diseases; consumption of sulfonylureas; Urine ketone positively while having symptoms of polyuria; diabetic ketoacidosis
Intervention groups
In the intervention group gliclazide-MR 30 mg twice a day and in the control group basal insulin 0.1-0.3 u/kg will be prescribed for three month, in addition to the drugs they receive for glycemic control.
Comparing the effect of basal insulin with modified-release gliclazide on glycemic control in type 2 diabetic patients with HbA1C above 10%
Public title
Investigating the effect of Gliclazide-MR on glycaemic control in type 2 diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes patients with HbA1C above 10%
Age over 30 years
Exclusion criteria:
Patients with kidney and liver failure
Heart failure
Stroke
Pregnancy
Previous receipt of gliclazide and insulin
Gastric problems
Consumption of sulfonylureas
Urine ketone positivity while having symptoms of polyuria
Diabetic ketoacidosis
Age
From 30 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
Patients will be divided into two groups using the block randomization method based on generated numbers by Random allocation software. Thus, in this software, first, the number of groups and the total determined sample size will be entered, and then in the block section, the Block randomization method will be implemented. According to the total sample size (90 patients), 23 blocks of 4 will be used. Then, the computer-generated numbers list will be given to the physician, and the physician will assign patients to groups according to the determined order by the software for entry into one of the groups.
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 Imam Khomeini University hospital- Urmia University of Medical Sciences
Street address
Imam Khomeini hospital, Modarres Blvd, Ershad Ave
City
Urmia
Province
West Azarbaijan
Postal code
57157-89397
Approval date
2023-06-21, 1402/03/31
Ethics committee reference number
IR.UMSU.HIMAM.REC.1402.043
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
HbA1C
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
High Performance Liquid Chromatography(HPLC)
2
Description
Fasting blood sugar (FBS)
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
High Performance Liquid Chromatography (HPLC)
3
Description
Two-hour blood sugar (BS 2hpp)
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
High Performance Liquid Chromatography (HPLC)
Secondary outcomes
1
Description
Excessive drinking and excessive urination
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Interview
2
Description
Weight
Timepoint
Before the intervention and 3 months after the intervention
Method of measurement
Weight scale
Intervention groups
1
Description
Intervention group: For patients, in addition to the drugs they receive for glycemic control, gliclazide-MR 30 mg (produced by Actoverco pharmaceutical company) twice a day will be prescribed for three months.
Category
Treatment - Drugs
2
Description
Control group: For patients, in addition to the drugs they receive for glycemic control, basal insulin 0.1-0.3 u/kg (produced by Pouyesh Daru Company) will be prescribed for three months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Dr. Ebrahim Mohhamadi
Street address
Imam Khomeini hospital, Modarres Blvd, Ershad Ave
City
Urmia
Province
West Azarbaijan
Postal code
57154-89397
Phone
+98 44 3345 7286
Email
mohammadi.e@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Saber Gholizadeh
Street address
Urmia University of Medical Sciences, Resalat Ave, Jahad Blvd, Urmia, Iran.
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 3009
Email
gholizadeh.s@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?