| CTRI Number |
CTRI/2017/03/008011 [Registered on: 03/03/2017] Trial Registered Prospectively |
| Last Modified On: |
01/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Usage of Dapagliflozin in the management of Type-2 Diabetes Mellitus in Indian patients |
|
Scientific Title of Study
|
Usage of Dapagliflozin - a Sodium Glucose Co-transporter inhibitor, in the management of Type-2 Diabetes Mellitus: A Real world evidence study in Indian patients |
| Trial Acronym |
FOREFRONT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D1690R00029 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijay Viswanathan |
| Designation |
Head and Chief Diabetologist |
| Affiliation |
MV Hospital Chennai India |
| Address |
MV Hospital
Chennai
India
Chennai
TAMIL NADU
600013
India |
| Phone |
|
| Fax |
|
| Email |
drvijay@mvdiabetes.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hardik Vasnawala |
| Designation |
TA lead |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
Block N1 12th Floor Manyata Embassy Business Park
Rechenahalli Outer Ring Road Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9902097245 |
| Fax |
|
| Email |
Hardik.Vasnawala@astrazeneca.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Kumar |
| Designation |
Manager Trials and Publications |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
Block N1 12th Floor Manyata Embassy Business Park
Rechenahalli Outer Ring Road Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9972365541 |
| Fax |
|
| Email |
amit.kumarak@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca Pharma India Ltd
Block N1, 12th Floor, Manyata Embassy Business Park
Rechenahalli, Outer Ring Road, Bangalore-560045
|
|
|
Primary Sponsor
|
| Name |
AstraZeneca Pharma India Ltd |
| Address |
Manayata Tech Park Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Paramesh Shamanna |
Bengalore Diabetes Centre |
Dibetes department
Bengalore Diabetes CentreBangalore
Bangalore
KARNATAKA |
9845010359
dr_paramesh@hotmail.com |
| Sujit Bhattacharya |
CMRI |
The Calcutta Medical Endocrinology Department Research Institute, 7/2, Diamond Harbour Road, Kolkata-700027, West Bengal
Kolkata
WEST BENGAL |
9874292170
sujit_dr@yahoo.com |
| Dr KN Manohar |
Dr KN Manohar Clinic |
Diabetes department
Dr Mahesh Babu Clinic, Hyderabad
Hyderabad
ANDHRA PRADESH |
9845205822
drmanohar_kn@yahoo.com |
| Dr Mahesh Babu |
Dr Mahesh Babu Clinic |
Diabetes department
Dr Mahesh Babu Clinic
Hyderabad
Hyderabad
ANDHRA PRADESH |
9489436110
crmb2004@yahoo.co.in |
| Dr Nadeem rais |
Dr Nadeem rais |
Diabetes Department
Dr Nadeem rais
Mumbai
Mumbai
MAHARASHTRA |
9821062696
nadeemrais@gmail.com |
| Dr K P Singh |
Fortis Medcentre |
Endocrinology Department S.C.O-11, Sector-11
Chandigarh
Chandigarh
CHANDIGARH |
9815311711
Drkp1292@gmail.com |
| K D Modi |
K D Modi clinic |
Diabetes department
K D Modi clinic
Hyderabad
Hyderabad
ANDHRA PRADESH |
9848131482
drmodisclinic@gmail.com |
| Dr Shailaja Kale |
Orange Diabetes Speciality Clinic |
Endocrinology Department
Orange Diabetes Speciality Clinic, Pune
Pune
MAHARASHTRA |
9822055458
drshailaja@yahoo.com |
| Dr Yogesh Kadam |
Poona Diabetes Centre |
Diabetes Department
Poona Diabetes Centre, Pune
Pune
MAHARASHTRA |
9823141402
poonadiabetescentre@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 28 |
| Name of Committee |
Approval Status |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Clinicom Bangalore |
Submittted/Under Review |
| Clinicom Bangalore |
Submittted/Under Review |
| Clinicom Bangalore |
Submittted/Under Review |
| Clinicom Bangalore |
Submittted/Under Review |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| Conscience Independent Ethics Committee (CIEC) |
Approved |
| ETHICS COMMITTEE OF SUNIL’S DIABETES CARE n’ RESEARCH CENTRE |
Approved |
| IEC-ARC Institutional Ethics committee For Ajanta Hospital and IVF Center, Uttar Pradesh. |
Approved |
| Institutional Ethics Committee B.M. Birla Heart Research Centre, Institutional Ethics Committee, 1/1, National Library Avenue, Kolkata |
Submittted/Under Review |
| Institutional Ethics Committee, The Calcutta Medical Research Institute, Kolkata. |
Approved |
| Integrity Ethics Committee, CHL-Hospitals |
Approved |
| Vijaya Ethics Committee |
Submittted/Under Review |
| Yalamanchi Hospital Ethics Committee, Vijayawada |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non-Interventional study |
There is no intervention in the study, this is purely non-interventional study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who provide written informed consent.
2. Patients with previously diagnosed Type-2 diabetes mellitus
3. Patients with inadequately controlled diabetes (HbA1c >7%) with existing anti-diabetic medications, prior to initiation of dapagliflozin treatment.
4. Patients who are taking dapagliflozin within last 3 months.
5.Patients who are having past medical records for demographic information, weight, blood pressure and HbA1c value at the time of dapagliflozin prescribed
|
|
| ExclusionCriteria |
| Details |
1.Patients with Type-1 diabetes mellitus
2. Patients with any medical condition which in the opinion of the investigator would interfere with safe completion of the study
3. Pregnant or lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in HbA1C |
6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in weight and BP |
6 month |
|
|
Target Sample Size
|
Total Sample Size="2000"
Sample Size from India="2000"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a non-interventional, multicentre, prospective, observational study to be conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per site. The study would enroll T2DM patients who are/were inadequately controlled (HbA1c >7%) with existing anti-diabetic medications and who have been prescribed dapagliflozin 3 months prior to study initiation. No study medication will be prescribed or administered as a part of study procedure. Patients, who have been treated as per Investigators’ routine clinical practice and prescribed dapagliflozin 3 months before will be screened for enrolment in study. Dosage of dapagliflozin and other medications should be as per the routine clinical practice and prescribing information. The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB). |