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Trial registered on ANZCTR


Registration number
ACTRN12624000033549
Ethics application status
Approved
Date submitted
8/08/2023
Date registered
15/01/2024
Date last updated
21/01/2024
Date data sharing statement initially provided
15/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of Dapagliflozin on Proteinuria in Type 2 Diabetic Patients.
Scientific title
Evaluating the effect of Dapagliflozin on Proteinuria in Type 2 Diabetic Patients.
Secondary ID [1] 310304 0
Nil
Universal Trial Number (UTN)
U1111-1296-1635
Trial acronym
DAPA-PROTEINURIA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 331003 0
Kidney disease 331004 0
Condition category
Condition code
Metabolic and Endocrine 327815 327815 0 0
Diabetes
Renal and Urogenital 327816 327816 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All the patients, fulfilling the inclusion criteria of this study would be offered Dapagliflozin 10 tablet mg once daily per-oral treatment for 12 weeks. This treatment would be given as home self-administered. Compliance would be checked by drug tablet return. 24 hour urinary proteins of these patients would measured at baseline and repeated at 12 weeks interval after treatment with Dapagliflozin.
Intervention code [1] 326684 0
Treatment: Drugs
Comparator / control treatment
Calcium Pantothenate 50 mg per oral tablet once daily for the same duration as intervention group i.e. 12 weeks. This will be home self-administered. Compliance would be checked by drug tablet return. Calcium Pantothenate does not affect the 24 hour urinary protein excretion. 24 hour urinary proteins of the control group would be measured at baseline and at 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 335663 0
Value of 24 hour urinary proteins.
Patients would be asked to self collect 24 hour urine over 24 hours. This sample would be checked in hospital Laboratory for the amount of proteins in milligrams.
Timepoint [1] 335663 0
Baseline and 12 weeks post-intervention commencement.
Secondary outcome [1] 425133 0
Urinary Tract Infections.
It would be checked by analyzing urine for bacteria/nitrates and white cells in patients who have symptoms suggestive of urinary tract infection.
Timepoint [1] 425133 0
Baseline, at the time when the patient become symptomatic of urinary tract intervention between the baseline and 12 weeks post intervention commencement, and 12 weeks post intervention commencement.
Secondary outcome [2] 425134 0
Genital Mycotic infections.
Done by clinical examination of genitalia in suspected cases reporting of genital itching or discharge.
Timepoint [2] 425134 0
Baseline by history, At the time when the patient become symptomatic of genital mycotic infections between the baseline and 12 weeks post intervention commencement by history and examination, and 12 weeks post intervention commencement by history.
Secondary outcome [3] 425226 0
Body weight. Checked in clinic on a digital scale.
Timepoint [3] 425226 0
Baseline and 12 weeks post-intervention commencement.

Eligibility
Key inclusion criteria
1. Age more than 16 years or older.
2. Gender: Any
3. Patients diagnosed as having type 2 diabetes mellitus (Fasting blood glucose of >126 mg/dl or HbA1C > 6.5 %) who are having proteinuria of more than 150mg / 24 hours already on maximum tolerated dose of Angiotensin Converting Enzyme Inhibitors (ACEi) or Angiotensin receptor Blockers (ARBs).
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with type 1 diabetes mellitus (SGLT2 inhibitors may precipitate Diabetic Ketoacidosis)
2. Pregnancy (SGLT2 inhibitors not licensed) and
3. Cancer.
4. Patients already on SGLT2 inhibitors
5. Patients on treatments which may impair glucose metabolism, such as immunosuppressant/immunomodulators and systemic or local steroid therapy.

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)
Permuted block randomization
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The data will be analyzed by using standard SPSS software version 23. For continuous data, the mean and standard deviation would be used to describe the distribution, and t-tests or analysis of variance (ANOVA) would be used to compare differences between two groups. For categorical data, frequency and percentage would be used to describe the distribution, and chi-square tests or Fisher’s exact tests would be used to compare differences between two groups. A P-value less than 0.05 would indicate statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
31/01/2025
Actual
Date of last data collection
Anticipated
30/04/2025
Actual
Sample size
Target
516
Accrual to date
Final
Recruitment outside Australia
Country [1] 25690 0
Pakistan
State/province [1] 25690 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 314516 0
Hospital
Name [1] 314516 0
MTI Lady Reading Hospital
Country [1] 314516 0
Pakistan
Primary sponsor type
Hospital
Name
MTI Lady Reading Hospital
Address
MTI Lady Reading Hospital, Peshawar City, Post Code 25000.
Country
Pakistan
Secondary sponsor category [1] 316496 0
None
Name [1] 316496 0
Address [1] 316496 0
Country [1] 316496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313557 0
Lady Reading Hospital Medical Teaching Institution Institutional Review Board
Ethics committee address [1] 313557 0
MTI Lady Reading Hospital, Peshawar City, Post Code 25000.
Ethics committee country [1] 313557 0
Pakistan
Date submitted for ethics approval [1] 313557 0
20/09/2022
Approval date [1] 313557 0
07/10/2022
Ethics approval number [1] 313557 0
507/LRH/MTI

Summary
Brief summary
To assess the effect of Dapagliflozin 10 mg on proteinuria in patients of type 2 diabetes mellitus.
Although extensively studied internationally, to the best of our knowledge no local study in Pakistan has been conducted to see the effect of Dapagliflozin on proteinuria in Pakistani type 2 diabetic patients. Therefore, we aim to study the above.
In this study a total sample size would be 516 patients with diabetes mellitus and proteinuria. The sample size is calculated with the help of OpenEpi sample size calculator, with confidence level (1-a) equal to 95%., power of test of 80% and previously calculated at least 30% reduction of albuminuria of 49.7 % with Dapagliflozin and 37.4 % with Placebo ( Heerspink HJ, Johnsson E, Gause-Nilsson I, Cain VA, Sjöström CD. Dapagliflozin reduces albuminuria in patients with diabetes and hypertension receiving renin-angiotensin blockers. Diabetes Obes Metab. 2016 Jun;18(6):590-7. doi: 10.1111/dom.12654. PMID: 26936519; PMCID: PMC4850750.)
All the patients, fulfilling the inclusion criteria of this study would be offered Dapagliflozin 10 mg once daily treatment in the intervention arm and placebo in the control arm after permuted block randomization. 24 hour urinary proteins of these patients would be repeated at 12 weeks interval after treatment with either Dapagliflozin or Placebo. Body weight of all the study participants would be measured at baseline and at 12 weeks. Urinary Tract Infections and Genital Mycotic infections would be seen at baseline and after 12 weeks of in both the intervention and control group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128538 0
Dr Nauman Wazir
Address 128538 0
Department of Diabetes and Endocrinology, MTI Lady Reading Hospital, Peshawar, Post code 25000, Pakistan.
Country 128538 0
Pakistan
Phone 128538 0
+923369190857
Fax 128538 0
Email 128538 0
nauman.wazir@lrh.edu.pk
Contact person for public queries
Name 128539 0
Dr Nauman Wazir
Address 128539 0
Department of Diabetes and Endocrinology, MTI Lady Reading Hospital, Peshawar, Post code 25000, Pakistan.
Country 128539 0
Pakistan
Phone 128539 0
+923369190857
Fax 128539 0
Email 128539 0
nauman.wazir@lrh.edu.pk
Contact person for scientific queries
Name 128540 0
Dr Nauman Wazir
Address 128540 0
Department of Diabetes and Endocrinology, MTI Lady Reading Hospital, Peshawar, Post code 25000, Pakistan.
Country 128540 0
Pakistan
Phone 128540 0
+923369190857
Fax 128540 0
Email 128540 0
nauman.wazir@lrh.edu.pk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator
Dr. Nauman Wazir
email: nauman.wazir@lrh.edu.pk


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19956Informed consent form  nauman.wazir@lrh.edu.pk 386370-(Uploaded-08-08-2023-18-56-31)-Study-related document.pdf
19957Ethical approval  nauman.wazir@lrh.edu.pk 386370-(Uploaded-08-08-2023-18-57-00)-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.