| CTRI Number |
CTRI/2023/10/059034 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
20/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on the effect of Dapagliflozin and Metformin combination on Insulin resistance and cardiovascular disease risk factors in subjects with type II diabetes mellitus |
|
Scientific Title of Study
|
Effect of Dapagliflozin and Metformin Combination on Insulin Resistance and Cardiovascular Disease Risk Factors in Drug Naïve Type II Diabetes Mellitus Patients in a Tertiary Care Hospital: An Open Label Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Abissha |
| Designation |
Post graduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Nagar
Kattankulathur
Chengalpattu district
Tamilnadu 603203
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Nagar
Kattankulathur
Chengalpattu district
Tamilnadu 603203
Kancheepuram
TAMIL NADU
632403
India |
| Phone |
9629596160 |
| Fax |
|
| Email |
sabissha96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jamuna Rani |
| Designation |
Professor and head, department of Pharmacology |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Nagar
Kattankulathur
Chengalpattu district
Tamilnadu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840279010 |
| Fax |
|
| Email |
hod.medpharm.ktr@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jamuna Rani |
| Designation |
Professor and head, department of Pharmacology |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Nagar
Kattankulathur
Chengalpattu district
Tamilnadu 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840279010 |
| Fax |
|
| Email |
hod.medpharm.ktr@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre
SRM Nagar
Kattankulathur
Chengalpattu district
Tamilnadu 603203
|
|
|
Primary Sponsor
|
| Name |
S Abissha |
| Address |
Postgraduate
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Nagar
Kattankulathur
Chengalpattu district
Tamilnadu 603203
|
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Abissha |
SRM Medical College Hospital and Research Centre |
Department of Pharmacology
SRM Medical College Hospital and Research Centre
SRM Nagar
Kattankulathur
Chengalpattu district
Tamilnadu 603203
Kancheepuram
TAMIL NADU |
9629596160
sabissha96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM INSTITUTIONAL ETHICS COMMITTEE BMHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tab. Metformin 500mg SR |
Tab. Metformin 500mg SR once daily in the morning after food for 12 weeks |
| Intervention |
Tab. Metformin-Dapagliflozin FDC (fixed dose combinaton) |
Tab. Metformin-Dapagliflozin FDC (Dapagliflozin 5mg and Tab. Metformin 500mg) once daily in the morning after food for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Male/female aged 18-60 years
2) Newly diagnosed with type 2 diabetes mellitus patients (FBS>126mg/dl and PPBS>200mg/dl)
3) HbA1c level 7% to 8%
4) Newly diagnosed type II diabetes with or without hypertension and dyslipidemia
|
|
| ExclusionCriteria |
| Details |
1) Diabetes with renal failure
2) Diabetes with liver failure
3) Pregnancy and lactation, psychiatric patients
4) Age above 60 years
5) Patients who are not willing to give informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) TyG index, TG to HDL C ratio from baseline to 12 weeks
2) Changes in FBS, PPBS & HbA1c, serum uric acid, systolic BP, body mass index, abdominal circumference, waist circumference, neck circumference, waist to hip ratio from baseline to 12 weeks
|
baseline to 12 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the tolerability & safety of monotherapy and combination therapy based on patient reported outcomes |
baseline to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - The data will be available in the publication
- For how long will this data be available start date provided 15-09-2024 and end date provided 15-02-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study hypothesis is to show that Metformin-Dapagliflozin combination is more efficacious than Metformin monotherapy in achieving glycaemic control and reducing insulin resistance and cardiovascular disease risk factors in type II diabetes mellitus patients |