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Trial registered on ANZCTR


Registration number
ACTRN12622000243718
Ethics application status
Approved
Date submitted
13/08/2021
Date registered
10/02/2022
Date last updated
10/02/2022
Date data sharing statement initially provided
10/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of efficacy of metformin plus dapagliflozin versus metformin plus insulin sensitizer in patients having diabetes mellitus type-2 in Pakistan.
Scientific title
Comparative assessment of anti-diabetic efficacy of metformin plus dapagliflozin with metformin plus insulin- sensitizer or secretagogues in patients with diabetes mellitus type-2 in Pakistan: A randomized trial.
Secondary ID [1] 304923 0
None
Universal Trial Number (UTN)
U1111-1268-4101
Trial acronym
CEMDI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus Type 2 323090 0
Condition category
Condition code
Metabolic and Endocrine 320664 320664 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A (Intervention group) will be given the combination of dapagliflozin plus metformin

The detail of drug administration is as following:

Group A:
1. Tablet Dapagliflozin 5mg-10mg, Once Daily, 3 months
2. Tablet Metformin 850-1000mg, Once Daily, 3 months

The starting dose of drug for each patient shall be according to judgement of physician in correlation of clinical and laboratory values. The dose shall be increased, but not exceeding the maximum, as per recommendations made by physician during follow-up of participants.
Intervention code [1] 321335 0
Treatment: Drugs
Comparator / control treatment
Group B (The comparator or Active control) shall receive a combination of metformin and insulin-sensitizers

1. Tablet Metformin 500mg-1000mg, Once Daily, 3 months
2. Tablet Glimiperide 50mg, Once Daily / Tablet Vildagliptin 50mg, Once Daily / Tablet Glabenclamide 5mg, Once daily / Tablet Sitagliptin 50mg, Once daily, All for 3 months

The starting dose of drug for each patient shall be according to judgement of physician in correlation of clinical and laboratory values. The dose shall be increased, but not exceeding the maximum, as per recommendations made by physician during follow-up of participants. The choice of drug from drug class of insulin sensitizers shall be at discretion of physician who may select depending upon clinical and laboratory values of each participant. Such drug shall be continued for use upto 3 month and no change over shall be made until the final data collection.
Control group
Active

Outcomes
Primary outcome [1] 328575 0
Glycated Hemoglobin (unit=%)

To be assessed through an independent laboratory. Blood sample will be collected by a person not involved in study, in a vacutainer containing EDTA. Necessary measures will be taken to control conditions to preserve sample.
Timepoint [1] 328575 0
First at time of recruitment
After 90 days from start of intervention
Primary outcome [2] 328576 0
Fasting Blood Glucose (mg/dl)

To be assessed using ACCUCHEK sugar meter. Subject will be asked not take any type of food after 9 PM and then visit research place at 9AM. Subject can drink only water during fasting period. The finger shall be pricked then and a drop of blood will be taken on glucose test strip to determine level of Blood glucose
Timepoint [2] 328576 0
First at time of recruitment
After 90 days from start of intervention
Primary outcome [3] 328577 0
Lipid profile including High Density Lipoprotein, Low density lipoprotein, Triglycerides and Cholesterol (unit=mg/dl)

To be assessed through an independent laboratory. Blood sample will be collected by a person not involved in study, in a vacutainer containing Clotting-Activator gel. Necessary measures will be taken to control conditions to preserve sample.
Timepoint [3] 328577 0
First at time of recruitment
After 90 days from start of intervention
Secondary outcome [1] 399500 0
Weight (Unit=Kg)

Weight will be assessed by an independent person not involved in study, using a calibrated weighing digital scale.
Timepoint [1] 399500 0
First at time of recruitment
After 90 days from start of intervention
Secondary outcome [2] 399503 0
Diastolic & Systolic Blood Pressure (Unit= mm of Hg)

To be assessed using calibrated Mercury BP apparatus. Patient upon reaching research place will be asked to take rest for 15 minutes. Then subject will be asked to sit. Cuff will be applied 2 inches above the cubital fossa as instructed in manual of manufacturer. Then blood pressure will be assessed as per Standard Operating Procedure (SOP).
Timepoint [2] 399503 0
First at time of recruitment
After 90 days from start of intervention
Secondary outcome [3] 399507 0
Postprandial Blood glucose (mg/dl)

To be assessed using ACCUCHEK sugar meter. This test will be conducted on the same day when Fasting Blood Glucose is being tested. Subject will be asked to take a proper meal just after the Fasting Blood Glucose Test and visit the research place after 2 hours of having meal. The finger shall be pricked then and a drop of blood will be taken on glucose test strip to determine level of Blood glucose
Timepoint [3] 399507 0
First at time of recruitment
After 90 days from start of intervention
Secondary outcome [4] 399638 0
C-Reactive Protein (Unit=mg/L)

To be assessed through an independent laboratory. Blood sample will be collected by a person not involved in study, in a vacutainer containing EDTA. Necessary measures will be taken to control conditions to preserve sample.
Timepoint [4] 399638 0
First at time of recruitment
After 90 days from start of intervention

Eligibility
Key inclusion criteria
1) Subject having Type-2 diabetes mellitus
2) Both Male & Female
3) Patients having glycated hemoglobin ranging between 6.5 to 12.5%
4) Age from 30 to 80 year
5) BMI greater than 23 kg/m^2
6) Patients who can understand and give consent for study
Minimum age
30 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients not using any oral anti diabetic combination from previous 4 weeks.
2) Subject having type 1 diabetes mellitus.
3) Person with history of blood pressure greater than 180 mm of Hg
4) Pregnancy
5) Patients with renal insufficiency
6) Lactating females
7) Dementia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized into two groups through computer based sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Around 84 subject will be recruitedas per inclusion and exclusion criteria. Sample size is calculated based on Cochran Formula (n=z^2 pq / e^2). Baseline data of clinical and laboratory values shall be assessed and recorded.
Subjects recruited will be randomized in two main groups through computer based randomization; Group A will be given the combination of dapagliflozin plus metformin while Group B will receive the combination of metformin plus insulin sensitizer or secretagouges.
The subjects of each group shall be assessed for final data collection of laboratory and clinical values after 3 months of the intervention. Before taking final data, the subjects shall be assessed for adherence of treatment or intervention through self-made medication adherence questionnaire. The subject scoring more than 70% percent adherence shall be considered admissible for the final data acquisition and analysis. The data acquired shall be subjected to statistical testing for possible difference and significant observations.
The data of recruited patients shall be assessed and be presented in frequencies and percentages for the socio-demographic data.
After the data collection of post-intervention, the statistics tools t-test and Fisher’s exact test will be used for the assessment of differences in primary and secondary outcomes. For the comparison of composite end points achieved by patient chi-square test will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2022
Actual
Date of last participant enrolment
Anticipated
30/04/2022
Actual
Date of last data collection
Anticipated
30/08/2022
Actual
Sample size
Target
84
Accrual to date
Final
Recruitment outside Australia
Country [1] 24021 0
Pakistan
State/province [1] 24021 0
PUNJAB

Funding & Sponsors
Funding source category [1] 309303 0
Self funded/Unfunded
Name [1] 309303 0
Muhammad Irfan Sohail Khan
Country [1] 309303 0
Pakistan
Primary sponsor type
Individual
Name
Dr. Malik Hassan Mehmood
Address
Chairperson Office, Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Allama Iqbal Road, Faisalabad city-38000, Punjab, Pakistan
Country
Pakistan
Secondary sponsor category [1] 310276 0
Individual
Name [1] 310276 0
Dr. Muhammad Ali Saqib
Address [1] 310276 0
HOD Office, Department of Medicine, Mian Muhammad Trust Hospital, Sargodha Road, Faisalabad city-38000, Punjab, Pakistan
Country [1] 310276 0
Pakistan
Other collaborator category [1] 281942 0
Individual
Name [1] 281942 0
Dr, Muhammad Imran Sohail
Address [1] 281942 0
Al-shifa Polyclinic, Islampura, Airport road, Faisalabad city-38000, Punjab, Pakistan
Country [1] 281942 0
Pakistan
Other collaborator category [2] 281943 0
Individual
Name [2] 281943 0
Dr. Mustafa Ijaz
Address [2] 281943 0
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Faisalabad city-38000, Punjab, Pakistan
Country [2] 281943 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309133 0
Government College University Faisalabad
Ethics committee address [1] 309133 0
Allama Iqbal Road, Faisalabad city-38000, Punjab, Pakistan
Ethics committee country [1] 309133 0
Pakistan
Date submitted for ethics approval [1] 309133 0
17/06/2021
Approval date [1] 309133 0
25/06/2021
Ethics approval number [1] 309133 0
GCUF/ERC/2271
Ethics committee name [2] 309147 0
Mian Muhammad Trust Hospital
Ethics committee address [2] 309147 0
New general bus stand, Sargodha road, Faisalabad city-38000, Punjab, Pakistan
Ethics committee country [2] 309147 0
Pakistan
Date submitted for ethics approval [2] 309147 0
28/06/2021
Approval date [2] 309147 0
30/06/2021
Ethics approval number [2] 309147 0
MMTH/21/878

Summary
Brief summary
It is hypothesized that combination of metformin with dapagliflozin is more effective than combination of metformin with insulin sensitizer in patient of type-2 diabetes mellitus.
Therefore this study is aimed to assess and compare of efficacy of different combination of oral anti-diabetics in type-2 diabetes mellitus. For this purpose, a sample of around 84 patients shall be recruited and their baseline data shall be recorded. After baseline data collection is completed, the subjected shall be randomly allocated into two groups, Group A (The intervention group) and Group B (The active control or comparator). Sample size is calculated by Cochran formula. After group allocation, the intervention shall be administered for 3 months after which final data collection shall be made. Individual data of patient shall remain confidential. Data obtained shall be subjected to statistical analysis for reporting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113098 0
Mr Muhammad Irfan Sohail Khan
Address 113098 0
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Allama Iqbal Road, Faisalabad city-38000, Punjab, Pakistan.
Country 113098 0
Pakistan
Phone 113098 0
+923316806092
Fax 113098 0
Email 113098 0
muhammadirfansohail7405@gmail.com
Contact person for public queries
Name 113099 0
Dr Mustafa Ijaz
Address 113099 0
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Allama Iqbal Road, Faisalabad city-38000, Punjab, Pakistan.
Country 113099 0
Pakistan
Phone 113099 0
+92412551354
Fax 113099 0
Email 113099 0
mustafaijaz78@gmail.com
Contact person for scientific queries
Name 113100 0
Dr Mustafa Ijaz
Address 113100 0
Department of Pharmacology, Faculty of Pharmaceutical Sciences, Government College University, Allama Iqbal Road, Faisalabad city-38000, Punjab, Pakistan.
Country 113100 0
Pakistan
Phone 113100 0
+92412551354
Fax 113100 0
Email 113100 0
mustafaijaz78@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data of all individuals, after necessary de-identification, shall be available for sharing that shall include demography, initial and final data of the study.
When will data be available (start and end dates)?
Immediately after publication of data and no end date
Available to whom?
The data shall be available to all researchers.
Available for what types of analyses?
Data can be available for meta-analysis and other study if proposed.
How or where can data be obtained?
Data can be obtained by sending request via email to Principal Investigator who may after checking the proposal or reason, shall share the data in reply to that email.
muhammadirfansohail7405@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12819Informed consent form  malikhassanmehmood@gcuf.edu.pk Signed Informed consent shall be sent only when re... [More Details]
12820Ethical approval    Two ethical approval, First from Government Colll... [More Details] 382510-(Uploaded-13-08-2021-17-10-34)-Study-related document.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.