| CTRI Number |
CTRI/2011/09/001983 [Registered on: 02/09/2011] Trial Registered Prospectively |
| Last Modified On: |
12/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
The purpose of this study is to learn if BMS-512148 (dapagliflozin),after 12 wks,can improve (decrease) blood pressure in patients with Type 2 diabetes mellitus with uncontrolled hypertension who are on an Angiotensin-converting enzyme inhibitor (ACEI) or an Angiotensin Receptor Blocker (ARB). |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Subjects With
Type 2 Diabetes With Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme (ACE) Inhibitor or Angiotensin Receptor Blocker (ARB) and an Additional Antihypertensive Medication |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| MB102-077 |
Protocol Number |
| NCT01195662 |
ClinicalTrials.gov |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Deepak Bachani |
| Designation |
Medical advisor |
| Affiliation |
Bristol-Myers Squibb India Pvt. Ltd |
| Address |
Bristol Myers Squibb India pvt ltd
6th floor Towers 1
Indiabulls Finance Centre
Senapati Bapat Marg Elphinstone (W)
Mumbai
MAHARASHTRA
400013
India |
| Phone |
022-66534264 |
| Fax |
02266103739 |
| Email |
deepak.bachani@bms.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Subashri Shivkumar |
| Designation |
Hub Unit Director |
| Affiliation |
Bristol Myers Squibb India Pvt. Ltd |
| Address |
Bristol Myers Squibb India Pvt. Ltd
6th floor Towers 1
Indiabulls Finance Centre
Senapati Bapat Marg Elphinstone (W)
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02266534245 |
| Fax |
022-66103739 |
| Email |
subashri.shivkumar@bms.com |
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Source of Monetary or Material Support
|
| The Pharmaceutical Company Sponsoring This Study Is Bristol-Myers Squibb |
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Primary Sponsor
Modification(s)
|
| Name |
Bristol Myers Squibb India Pvt Ltd |
| Address |
6th floor Towers 1
Indiabulls Finance Centre
Senapati Bapat Marg Elphinstone (W)
Mumbai - 400013
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| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
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Countries of Recruitment
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Australia
Colombia
Denmark
Finland
Germany
Hungary
Mexico
Poland
United Kingdom
United States of America |
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Sites of Study
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| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jaspal Arneja |
Arneja Heart Institute |
Arneja Heart Institute,123, Ramdaspeth, Nagpur- 440010,Maharashtra India
Nagpur
MAHARASHTRA |
09823275423
Jaspalarneja_200@yahoo.com |
| Dr Joseph Asirvatham |
Arthur Asirvatham Hospital |
Pranav Diabetes Centre & PACE Clinical Research, No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banaswadi, Bangalore - 560043, Karnataka, India
Bangalore
KARNATAKA |
9443881776
drajasirvatham@yahoo.co.in |
| DrRamalingam Srinivasan |
G. Kuppusamy Naidu Memorial Hospital |
G. Kuppusamy Naidu Memorial Hospital,Post Box No. 6327, Pappanaicampalayam, Coimbatore - 641037, Tamil Nadu,India
Coimbatore
TAMIL NADU |
09600866692
srinir02@gmail.com |
| Dr Mathew Thomas |
Health and Research Centre |
Health and Research Centre, 1st Floor, Devi Scans building, Kumarapuram, Medical College P.O, Thiruvananthapuram- 695011, Kerala, India
Thiruvananthapuram
KERALA |
09447089285
healthtrials@gmail.com |
| Dr Jayaprakash Appajigol |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre |
KLES Dr Prabhakar Kore Hospital and Medical Research Centre, JNMC Campus, Nehru Nagar, Belgaum - 590010, Karnataka, India
Belgaum
KARNATAKA |
08312475477
drjaypee@rediffmail.com |
| Dr Hemanga Barman |
M.V. Hospital for Diabetes (P) Ltd. |
M.V. Hospital for Diabetes (P) Ltd. & Diabetes Research Centre, No 4, West Mada Church Street, RoyaPuram, Chennai - 600013, Tamil Nadu, India
Chennai
TAMIL NADU |
04425954915
drbarmanh007@rediffmail.com |
| Dr Naveen Chander Reddy |
Mediciti Hospitals |
Mediciti Hospitals, 5-9-22, Secretriat Road, Hyderabad - 500063, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH |
04027631503
Prodduturnaveen@yahoo.co.in |
| Dr Ravikumar Sethuraman |
Meenakshi Mission Hospital And Research Centre |
Meenakshi Mission Hospital & Research Centre
Lake Area,Melur Road
Madurai- 625 107
Tamil Nadu, India
Madurai
TAMIL NADU |
914524263000
ravekumar24@gmail.com |
| Dr G M Prasad |
Pranav Diabetes Centre & PACE Clinical Research |
Pranav Diabetes Centre & PACE Clinical Research, No. 53, Nanda Complex, Ramamurthy Nagar Main Road, Banaswadi, Bangalore - 560043, Karnataka, India
Bangalore
KARNATAKA |
8025450070
paceclinicalresearch@gmail.com |
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Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Bangalore Central Ethics Committee for Dr. Gurumallappa Mahadev Prasad |
Approved |
| Central India Medical Research Ethics Committee Nagpur for Dr. J. Arneja Singh |
Approved |
| Ethical Review Board at Meenakshi Mission Hospital and Research Centre |
Approved |
| Ethics Committee at M V Hospital for Diabetes |
Approved |
| Ethics Committee of KLE University |
Approved |
| Independent Human Ethics Committee, Thiruvananthapuram for Dr. Mathew Thomas |
Approved |
| Institutional Ethics Committee for G. Kuppusamy Naidu Memorial Hospital |
Approved |
| Institutional Review Board for Dr. Ashirvatham |
Approved |
| Medicity Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
Type 2 Diabetes , |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dapagliflozin |
Tablets, Oral, 10 mg QD, once daily, Up to 12 weeks |
| Intervention |
Dapagliflozin |
Tablets, Oral, 5 mg QD, once daily,
Up to 12 weeks |
| Comparator Agent |
Placebo |
Tablets, Oral, 0 mg QD, once daily,
Up to 12 weeks |
|
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
89.00 Year(s) |
| Gender |
Both |
| Details |
Males and females, 18 to 65 years old, with type 2 diabetes with inadequate
glycemic control HbA1c between 7-10% and uncontrolled hypertension SBP 140-165 and DBP 85-105. Upper Limit of age of 65 years is in accordance with conditions set by Drug Controller General (India) for subjects participating from Indian sites.
Subjects must have a mean 24 hr blood pressure more than or equal to 130/80 determined by ABPM within 1 week prior to Day 1 visit.
Stable dose of oral antidiabetic agent (OAD) for 6 weeks (12 wks for TZD) and a stable dose of ACEI or ARB and 1 additional antihypertensive medication for 4 weeks
C-peptide more than or equal to .08 ng/mL
Body Mass Index less than or equal to 45.0 kg/m2
Serum creatinine < 1.50 mg/dL for men or < 1.40 mg/dL for women |
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| ExclusionCriteria |
| Details |
AST and /or ALT 3.0 times the upper limit of normal (ULN)
Serum total bilirubin more than 1.5 X ULN
Creatinine kinase more than 3 X ULN
Symptoms of severely uncontrolled diabetes
History of malignant or accelerated hypertension
Currently unstable or serious cardiovascular, renal, hepatic, hematological,oncological, endocrine, psychiatric, or rheumatic diseases |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Centralized |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline in seated systolic blood pressure |
After 12 weeks |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Change from baseline in HbA1c |
After 12 weeks |
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Target Sample Size
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Total Sample Size="765"
Sample Size from India="73"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
|
05/09/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/09/2010 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
The current trial is designed to evaluate the effects of dapagliflozin on blood pressure when used in subjects with type 2 diabetes (T2DM) who have inadequate glycemic control and inadequately controlled hypertension while taking an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) and an additional antihypertensive medication.
In dapagliflozin Phase 2 and 3 studies, dose-dependent reductions in blood pressure have been observed in doses between 1.0 mg to 10 mg in monotherapy studies as well as in add-on to other oral hypoglycemic agents or insulin studies. These blood pressure reductions are consistent with the known osmotic diuretic effect of dapagliflozin, which results from its inhibition of proximal renal tubular glucose and sodium re-absorption. |