| CTRI Number |
CTRI/2022/12/048622 [Registered on: 30/12/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Dapagliflozin add-on to metformin therapy in diabetic patients |
|
Scientific Title of Study
|
Dapagliflozin add-on to metformin in type 2 diabetes mellitus those who are inadequatively controlled on a stable dose of metformin- In Shahjahanpur district population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditya kumar |
| Designation |
postgraduate student |
| Affiliation |
Varunarjun medical college and rohilkhand hospital |
| Address |
Varunarjun medical college and rohilkhand hospital banthara shahjahanpur uttarpradesh
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8433274523 |
| Fax |
|
| Email |
adi9458701139@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Aditi Srivastava |
| Designation |
Professor and HOD |
| Affiliation |
Varunarjun medical college and rohilkhand hospital |
| Address |
Varunarjun medical college and rohilkhand hospital banthara shahjahanpur uttarpradesh
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9532417395 |
| Fax |
|
| Email |
generalmedicine9090@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aditya kumar |
| Designation |
postgraduate student |
| Affiliation |
Varunarjun medical college and rohilkhand hospital |
| Address |
Varunarjun medical college and rohilkhand hospital banthara shahjahanpur uttarpradesh
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8433274523 |
| Fax |
|
| Email |
adi9458701139@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun arjun medical college and rohilkhand hspital |
|
|
Primary Sponsor
|
| Name |
Aditya kumar |
| Address |
Varunarjun medical college and rohilkhand hospital banthara shahjahanpur uttarpradesh |
| 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 |
| Aditya kumar |
Varunarjun medical college and rohilkhand hospital |
General Medicine department Varunarjun medical college and rohilkhand hospital banthara shahjahanpur uttarpradesh
Shahjahanpur
UTTAR PRADESH |
8433274523
adi9458701139@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee , VAMC |
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 |
| Intervention |
Dapagliflozin add-on to metformin in type 2 diabetes mellitus |
Dapagliflozin add-on to metformin in type 2 diabetes mellitus those who are inadequatively controlled on a stable dose of metformin |
| Comparator Agent |
The difference in all
the mentioned parameters will be used to determine the efficacy of
DAPAGLIFLOZIN. Parameter before and after adding of dapagliflozin will be compared |
Pateints with type II DM on Metformin 1-2gm per day having Inadequate Glycemic
control will be subjected to
further assessment DAPAGLIFLOZIN 10mg tablet once daily orally. The patients will be followed up
in OPD every month till 3 months. Blood Pressure, Fasting Blood sugar, 2
hours Post prandial Blood sugar, Body weight will be regularly assessed
during routine clinic visits. At the end of 3 months, Blood Pressure, Body
weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post
prandial Blood sugar and HbA1c will be assessed. The difference in all
the mentioned parameters will be used to determine the efficacy of
DAPAGLIFLOZIN |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with T2DM inadequately controlled with Metformin 1-2 gm per day
2. Those patients who are unable to tolerate further increase in further dose of Metformin
3. Patients aged 30 to 70 years
4. HbA1C 7.0% to 9.0%
|
|
| ExclusionCriteria |
| Details |
1. Patient who are on insulin
2. Patient described any other anti diabetic medication after adding Dapagliflozin to Metformin
3. Patients in which dose of metformin has to be altered
4. Patients with renal insufficiency (GFR lress than 30ml/min/1.73m2)
5. Patients who are known case of urinary tract infection , structural abnormalities of urinary tract.
6. Patients with acute complications of diabetes mellitus
7. Patients with hypersensitivity to drug
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To access the effect of Dapagliflozin on:
1. Glycemic parameters
2. Lipid profile
3. Bmi
4. Blood pressure
5. To study the efficacy of Dapagliflozin
|
Selected patients will be evaluated for Blood
Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin
creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c on first visit. These patients will be followed up in OPD every month till 3 months. At the end of 3 months, Blood Pressure, Body
weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2023 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pateints who present to the Varunarjun Medical College and Rohilkhand Hospital with type II DM on Metformin 1-2gm per day will be subjected to further assessment. The selected patients will be evaluated for Blood Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Urinary albumin creatinine ratio (UACR), Urine R/m, Fasting Blood sugar, 2 hours Post parandial Blood sugar and HbA1c . Patients with Inadequate Glycemic control will be selected for the study. They will prescribed with DAPAGLIFLOZIN 10mg tablet once daily. The patients will be followed up in OPD every month till 3 months. Blood Pressure, Fasting Blood sugar, 2 hours Post prandial Blood sugar, Body weight will be regularly assessed during routine clinic visits. At the end of 3 months, Blood Pressure, Body weight, CBC, KFT, LFT, Lipid Profile, Fasting Blood sugar, 2 hours Post prandial Blood sugar and HbA1c will be assessed. The
difference in all the mentioned parameters will be used to determine the
efficacy of DAPAGLIFLOZIN |