| CTRI Number |
CTRI/2024/07/071196 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness and Safety of diabetic drugs in diabetic participants |
|
Scientific Title of Study
|
Comparison of Effectiveness and Safety of Dapagliflozin and Empagliflozin in Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manu Arya |
| Designation |
Junior Resident MD pharmacology |
| Affiliation |
Teerthanker Mahaveer University Medical College and Research Centre |
| Address |
Department of pharmacology Teerthanker Mahaveer Medical College and Research Centre, Moradabad Uttar Pradesh, 244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09289593077 |
| Fax |
|
| Email |
drmanuarya16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prithpal Singh Matreja |
| Designation |
Professor & Head Pharmacology |
| Affiliation |
Teerthanker Mahaveer University Medical College and Research Centre |
| Address |
Department of pharmacology Teerthanker Mahaveer Medical College and Research Centre, Moradabad Uttar Pradesh,244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9855001847 |
| Fax |
|
| Email |
drpsmatreja@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu Arya |
| Designation |
Junior Resident MD pharmacology |
| Affiliation |
Teerthanker Mahaveer University Medical College and Research Centre |
| Address |
Department of pharmacology Teerthanker Mahaveer Medical College and Research Centre, Moradabad Uttar Pradesh,244001
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
09289593077 |
| Fax |
|
| Email |
drmanuarya16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College and Research Centre, Moradabad, Uttar Pradesh ,244001,India |
|
|
Primary Sponsor
|
| Name |
Dr Manu Arya |
| Address |
Department of pharmacology Teerthanker Mahaveer Medical College and Research Centre, Moradabad Uttar Pradesh 244001 |
| Type of Sponsor |
Other [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 Manu Arya |
Teerthanker Mahaveer Medical College and Research Centre, Moradabad Uttar Pradesh |
Department of pharmacology Teerthanker Mahaveer Medical College and Research Centre, Moradabad Uttar Pradesh
Moradabad
UTTAR PRADESH |
09289593077
drmanuarya16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMU Moradabad- Institutional Committee (TMU-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dapagliflozin 5mg OD |
Dapagliflozin 5mg OD |
| Intervention |
Empagliflozin 25mg OD for 20 weeks |
Empagliflozin 25mg OD for 20 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All Patients with Type2 diabetes mellitus as per ADA guidelines
Patients of either gender with age more than 18 years.
Patients giving written informed consent.
|
|
| ExclusionCriteria |
| Details |
Pregnant & lactating women.
Patients not complying with the study protocol.
Patients with underlying comorbid conditions like recurrent UTI, chronic renal diseases.
Patients with co-morbid conditions like malignancy, psychiatric disorders, substance abuse
Patients with concomitant medications likely to interfere with glycemic control e.g.: Steroids, Beta-blockers, Thiazide Diuretics
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Fasting Plasma Glucose(FPG), glycosylated haemoglobin(HbA1c), NT-pro BNP , Kidney function Test(KFT)
|
Fasting Plasma Glucose(FPG), glycosylated haemoglobin(HbA1c), NT-pro BNP , Kidney function Test(KFT)
follow up after 4 weeks and 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Adverse drug monitoring using a pre-validated ADR checklist along with spontaneous reporting
|
Changes in NT-proBNP, KFT & FPG from baseline to End of the study follow up after 4 weeks & 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 4 |
|
Date of First Enrollment (India)
|
05/08/2024 |
| 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="6"
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 - NO
|
|
Brief Summary
|
Title: Comparison of Effectiveness and Safety of Dapagliflozin and Empagliflozin in Type 2 Diabetes Mellitus Aim: To study the effectiveness and safety of dapagliflozin and empagliflozin in T2DM Objective: To compare the effectiveness of empagliflozin in T2DM. To compare the effectiveness of dapagliflozin in T2DM. To compare the safety of dapagliflozin in T2DM To compare the safety of empagliflozin in T2DM To compare the effectiveness and safety of dapagliflozin and empagliflozin in T2DM Type of Study: Randomized parallel-group active control trial Source of data collection: This study will be conducted in the Department of Pharmacology and General Medicine, Teerthanker Mahaveer Medical College and Research Center All patients diagnosed with T2DM in the Department of General Medicine at Teerthanker Mahaveer Medical College and Research Center Sample Size: 104 Site of study: TMMC&RC Moradabad, Uttar Pradesh Inclusion Criteria: All Patients with Type2 diabetes mellitus as per ADA guidelines Patients of either gender with age more than 18 years. Patients giving written informed consent. Exclusion Criteria: Pregnant & lactating women. Patients not complying with study protocol. Patients with underlying comorbid conditions like recurrent UTI, and chronic renal diseases Patients with co-morbid conditions like malignancy, psychiatric disorders, substance abuse Patients with concomitant medications likely to interfere with glycemic control e.g.: Steroids, Beta-blockers, Thiazide Diuretics Outcome measuring tool •Effectiveness End Points : Primary end Points – Change in HbA1c from baseline to end of study. Secondary end Points – Changes in NT-pro BNP, KFT & FPG from baseline to End of the study. •Safety End Points: Incidence of treatment-emergent adverse events. |