| CTRI Number |
CTRI/2014/08/004872 [Registered on: 13/08/2014] Trial Registered Prospectively |
| Last Modified On: |
28/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events (DECLARE-TIMI 58) in Type II diabetes patients. |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes (DECLARE) |
| Trial Acronym |
DECLARE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D1693C00001 Final 1.0, dated 05 April 2013 |
Protocol Number |
| NCT01730534 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prasanna Kumar |
| Designation |
Sr. Consultant in Endocrinology |
| Affiliation |
Bangalore Diabetes Hospital |
| Address |
Bangalore Diabetes Hospital
16/M Thimmaiah Road,
Millers Tank Bed Area
Vasanthnagar,
Bangalore
KARNATAKA
560052
India |
| Phone |
00918022372980 |
| Fax |
00918022372981 |
| Email |
drkmpk@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mr Tapankumar M Shah |
| Designation |
Country Head - Site Management and Monitoring – India |
| Affiliation |
AstraZeneca Pharma India Ltd. |
| Address |
AstraZeneca Pharma India Ltd.
Block N1, 12th Floor,
Manyata Embassy Business park
Rachenahalli, Outer Ring Road,
Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9535104975 |
| Fax |
00918067748857 |
| Email |
tapankumar.shah@astrazeneca.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mr Tapankumar Shah |
| Designation |
Country Head – Clinical Operations |
| Affiliation |
AstraZeneca Pharma India Ltd. |
| Address |
Block N1, 12th Floor, Manyata Embassy Business Park Rachenahalli, Outer Ring Road,
Bangalore- 560024, Karnataka, India
Bangalore
KARNATAKA
560024
India |
| Phone |
00918067748006 |
| Fax |
00918023622015 |
| Email |
Tapankumar.Shah@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca AB (Study Sponsor company)
151 85 Södertälje, Sweden |
|
|
Primary Sponsor
|
| Name |
AstraZeneca AB |
| Address |
151 85 Södertälje, Sweden |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bristol Myers Squibb India Pvt Ltd |
Bristol Myers Squibb India Pvt. Ltd
6th floor, Tower 1 and 2, Indiabulls finance centre
SB Marg, Elphinstone(W)
Mumbai 400 013 |
|
|
Countries of Recruitment
|
Argentina
Australia
Belgium
Brazil
Bulgaria
Canada
China
Czech Republic
France
Germany
Hungary
India
Israel
Italy
Japan
Mexico
Netherlands
Philippines
Poland
Republic of Korea
Romania
Russian Federation
Slovakia
South Africa
Spain
Sweden
Taiwan
Thailand
Turkey
Ukraine
United Kingdom
United States of America
Viet Nam |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr PS Iyengar |
Care Institute of Medical Sciences |
Opp. Panchamrut Bunglow,
Nr. Shukan Mall, Off. Science City Road,
Sola, Ahmedabad, Gujarat – 380060
Ahmadabad
GUJARAT |
00917927712771
00917927712777
ps.iyengar@cimshospital.org |
| Dr Nihal Thomas |
Christian Medical College MC |
IDA Scudder Road, Vellore Tamil Nadu - 632004
Vellore
TAMIL NADU |
00914162282694
00914164205844
nihal_thomas@yahoo.com |
| Dr Chittranjan Yajnik |
KEM Hospital |
Diabetes Unit,
6th Floor, Banoocayaji Building, Sardar Mudliar Road, Rasta Peth,
Pune, Maharashtra - 411 011
Pune
MAHARASHTRA |
00912066405731
00912026111958
diabetestrials@yahoo.com |
| Dr Vageesh Ayyar |
St. Johns Medical College and Hospital |
Department of Endocrinology
Sarjapur Road,
Bangalore, Karnataka-560034
Bangalore
KARNATAKA |
00918022065711
0918025635313
vagayyar@gmail.com |
| Dr Raveendra K R Associate Professor |
Victoria Hospital |
Department of Medicine,
Room No 72/A, 2nd Floor, Medicine New ‘C’ Block,
Victoria Hospital, Fort, Bangalore – 560002, Karnataka
Bangalore
KARNATAKA |
919448134587
918026706260
drkrraveendra@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Christian Medical College Institutional Review Board, Office of Research Carman Block, 1st Floor, CMC Bagayam, Vellore- 632002 |
Approved |
| Ethics Committee of Bangalore Medical college & Research Institute, 1st Floor, Bangalore Medical college & Research Institute, K.R. road, Fort, Bangalore 560002 |
Approved |
| Ethics Committee of CIMS, Nr. Shukan Mall, Off. Science City Road, Sola, Ahmedabad, Gujarat - 380060, India |
Approved |
| Institutional Ethical Review Board, St. John’s Medical College and Hospital Sarjapur Road, Bangalore-560034 |
Approved |
| KEM Hospital Research Centre Ethics Committee, Sardar Mudliar Road, Rasta Peth, Pune - 411 011 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Diabetes Mellitus, Non-Insulin-Dependent
High Risk for Cardiovascular Event, (1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin |
Taken orally for up to 6 years |
| Comparator Agent |
Placebo |
Taken orally for up to 6 years |
|
Inclusion Criteria
Modification(s)
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• Provision of informed consent prior to any study specific procedures
• Female or male aged more than or equal to 40 years and less or equal 65 years
• Diagnosed with Type 2 Diabetes
• High Risk for Cardiovascular events
|
|
| ExclusionCriteria |
| Details |
• Diagnosis of Type 1 diabetes mellitus History of bladder cancer or history of radiation therapy to the lower abdomen or pelvis at any time
• Chronic cystitis and/or recurrent urinary tract infections
• Pregnant or breast-feeding patients |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ] |
Time to first event included in the composite endpoint of CV death, MI or ischemic stroke [ Time Frame: up to 6 years ] |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first event of Hospitalization for Congestive Heart Failure
Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization
Time to All-cause mortality
Body weight change from baseline |
6 years |
|
|
Target Sample Size
|
Total Sample Size="17150"
Sample Size from India="200"
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 |
Date of First Enrollment (India)
Modification(s)
|
16/10/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/04/2013 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="6"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients with Type 2 Diabetes. Total duration of the study is up to 6 years. Total of 17150 subjects will be randomized globally from approximately 1000 sites from 33 countries. The primary outcome measures will be time to first event included in the composite endpoint of CV death, MI or ischemic stroke for a period of up to 6 years.And secondary outcome measures will be:· Time to first event of Hospitalization for Congestive Heart Failure for a period of up to 6 years,· Time to first event included in the composite endpoint of CV death, MI, ischemic stroke, hospitalization for heart failure, hospitalization for unstable angina pectoris, or hospitalization for any revascularization for a period of up to 6 years,· Time to all-cause mortality for a period of up to 6 years, and Body weight change from baseline for a period of up to 6 years. |